Drug Recalls

About this recall:

Bionpharma is voluntarily recalling a single batch (lot) of Atovaquone Oral Suspension, 750 mg per 5 mL (NDC 69452-0252-87) to the consumer level due to contamination with Cohnella bacteria. The product was manufactured by CoreRx and distributed by Bionpharma.

This product is an antimicrobial drug indicated for prevention of a certain type of infection known as Pneumocystis jirovecii pneumonia (formerly known as PCP for Pneumocystis carinii pneumonia) in adults and adolescents aged 13 years and older. The recall is for lot #2310083 with expiration date of September 2025. The lot number is listed on the side panel of the manufacturer’s bottle or the bottom flap of the manufacturer’s carton.

What this means to you:

In patients with a weakened immune system (immunocompromised patients), the potential exists that microbial contamination of atovaquone oral suspension could result in serious, life-threatening infections such as inflammation of the heart and permanent damage to soft tissue. To date, Bionpharma has not received any reports of adverse events related to this recall.

Consumers that have the recalled NDC and lot number should stop using the product and return to the place of purchase. Consumers with questions regarding this recall can contact Bionpharma by phone at (888) 235-2466 (Monday through Friday 9 AM to 5 PM EST) or via email at drugsafety@bionpharma.com. Consumers should contact their healthcare provider if they have experienced any problems that may be related to taking or using the recalled lot of the drug.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:

American Health Packaging on behalf of BluePoint Laboratories is voluntarily recalling 21 batches of Potassium Chloride Extended-Release (ER) capsules in the strength of 750 mg which is equivalent to 10 mEq of potassium. The recall is to the consumer level due to failed dissolution.

For lot recalls, the lot/batch information and expiration date for the recalled product can be viewed by clicking on the link to the FDA Recall Notification found on the following page. Potassium Chloride ER Capsules are used for the treatment of patients with low potassium (hypokalemia) and are packaged in bottles of 100-count (NDC 68001-0396-00) and 500-count (NDC 68001-0396-03) capsules.

What this means to you:

If the potassium chloride ER capsules do not dissolve properly, high potassium levels (hyperkalemia) may occur which can result in irregular heartbeat that can lead to cardiac arrest. For patients who require chronic use of potassium chloride, especially in those with underlying conditions (high blood pressure, heart failure, or kidney dysfunction), the potential exists for high potassium levels to result in serious adverse events such as heart arrythmias, severe muscle weakness, or death. To date, the company has not received any reports of hyperkalemia or serious events from sources related to this recall.

Consumers that have Potassium Chloride ER Capsules with a recalled NDC and lot number should consult with their health care professional (HCP) before they stop using the product. Consumers should also contact their HCP if they have experienced any problems that may be related to taking or using this drug product. Consumers should call Sedgwick, at 1-855-695-8564, Monday to Friday, 8:00 am to 5:00 pm EST for return instructions and further
information.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:

Endo has voluntarily recalled one lot of Clonazepam Orally Disintegrating Tablets 0.25 mg. Product may appear as Clonazepam Orally Disintegrating Tablets 0.125 mg in a 60-count pack. The recall is to the consumer level and is due to mislabeling where an incorrect strength appears on the cartons of some packs (shown as 0.125 mg and not 0.25 mg) due to an error at a third-party packager. The blister strips inside the product pack reflect the correct strength of 0.25 mg.

Clonazepam Orally Disintegrating Tablets are indicated for use as an add-on therapy for various seizure disorders (Lennox-Gastaut syndrome, akinetic, myoclonic). Additionally, the product is approved for panic disorder. The drug is packaged in cartons of 60 tablets; the package labels include the product name, strength, lot number, and expiration date, and the National Drug Code (NDC) number 49884-0307-02; impacted units will display the NDC code 49884-0306-02.

What this means to you:

Patients who receive a two-fold overdose of clonazepam would be at risk for the adverse effects of sedation, dizziness, confusion, and problems with coordination. The potential exists for significant, possibly life-threatening, breathing problems especially in patients with lung disease, patients receiving near maximal doses, and patients taking other medications that could also cause problems breathing. To date, Endo has not received any reports of adverse events associated with this product lot recall.

Consumers who have unused, recalled 60-tablet cartons of Clonazepam Orally Disintegrating tablets, USP 0.25 mg which may also appear as Clonazepam Orally Disintegrating tablets, USP 0.125 mg with the lot number 550147301 should discontinue use of the product. If a patient took a 0.25 mg dose rather than the intended 0.125 mg dose, they are advised to consult a health care professional. Consumers with questions regarding this recall can contact Inmar by telephone at 877-890-0765 (Monday through Friday, 9 a.m. to 5 p.m. ET) or by email at rxrecalls@inmar.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:

Glenmark is voluntarily recalling 114 batches of Potassium Chloride Extended-Release (ER) capsules in the strength of 750 mg which is equivalent to 10 mEq of potassium. The recall is to the consumer level due to failed dissolution. For lot recalls, the lot/batch information and expiration date for the recalled product can be viewed by clicking on the link to the FDA Recall Notification found on the following page.

Potassium Chloride ER Capsules are used for the treatment of patients with low potassium (hypokalemia) and are packaged in bottles of 100-count (NDC 68462-0357-01) and 500-count (NDC 68462-0357-05) capsules.

What this means to you:

If the potassium chloride ER capsules do not dissolve properly, high potassium levels (hyperkalemia) may occur which can result in irregular heartbeat that can lead to cardiac arrest. For patients who require chronic use of potassium chloride, especially in those with underlying conditions (high blood pressure, heart failure, or kidney dysfunction), the potential exists for high potassium levels to result in serious adverse events such as heart
arrythmias, severe muscle weakness, or death. To date, the company has not received any reports of hyperkalemia or serious events from sources related to this recall.

Consumers that have Potassium Chloride ER Capsules with a recalled NDC and lot number should consult with their health care professional (HCP) before they stop using the product. Consumers should also contact their HCP if they have experienced any problems that may be related to taking or using this drug product. Consumers should call Inmar Rx Solutions at 1-877-883-9273, Monday to Friday, 9:00 am to 5:00 pm EST for return instructions and for further information.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:

Dr. Reddy’s is voluntarily recalling 6 lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg to the consumer level due to powder discoloration in some packets resulting in decreased drug potency. The problem was found during a stability test, in addition to customer complaints. Product lots being recalled carry the following NDC numbers: 43598-0097-30 or 43598-0477-30.

This medication is FDA-approved to decrease blood phenylalanine (Phe) levels in certain adult and pediatric patients 1 month of age and older with elevated Phe levels. It is packaged in individual packets (30 per carton).

What this means to you:

Lower levels of sapropterin will lead to increased Phe levels. In infants and children if the Phe levels remain increased, permanent brain damage could occur, including irreversible intellectual disability, developmental delay, and seizures. Additionally, elevated levels during pregnancy, especially in early pregnancy, are associated with decreased head size and heart disease in the infant.

Consumers who have lots of sapropterin dihydrochloride powder for oral solution 100 mg which are being recalled should contact their healthcare professional before stopping use. Consumers who have a lot which is being recalled should return it to the place of purchase. Questions regarding this recall can be directed to Dr. Reddy’s by calling 866-733-3952 between 9 a.m. to 5 p.m. EST Monday through Friday. Patients should contact their healthcare professional if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration.

For more information regarding this FDA Recall notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:

Avkare is voluntarily recalling lot # AW0221A (expiration 08/2025) of Atovaquone Oral Suspension, USP 750 mg/5 mL (NDC # 50268-086-12) to the consumer level due to the potential for Bacillus cereus contamination.

Atovaquone oral suspension is FDA-approved for prevention and treatment of a certain type of pneumonia, Pneumocystis jiroveci pneumonia (PCP), in adults and children 13 years of age and older who cannot take other medications, such as trimethoprim-sulfamethoxazole.

What this means to you:

In patients with a weakened immune system, the contaminated product could lead to serious, life-threatening infections, such as inflammation of the heart (endocarditis) or severe soft tissue infections.

Consumers that have product which is being recalled should stop using the product and return it to the place of purchase or discard. Consumers with questions regarding this recall can contact Avkare by phone at 1-855-361- 3993 or drugsafety@avkare.com, Monday through Friday, 9 am to 5 pm Eastern Time. Consumers should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:

Amneal is voluntarily recalling 4 lots of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5 mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, to the consumer level. Some bottles may have been overfilled which can result in an over potent dosing regimen. The recommended maximum daily dose is up to 2 gm/day, and patients prescribed a dosing regimen of 500 mg/10 mL would exceed this daily allowance, which may be harmful to patients with kidney insufficiency. The following NDCs and lot numbers are being recalled.

NDC Number	Lot	Expiration Date	Pack Size
69238-2261-03	22613003A	09/2025	80 mL
69238-2261-07	22613004A	09/2025	150 mL
69238-2261-07	22613005A	09/2025	150 mL
69238-2261-05	22613005B	09/2025	300 mL

Vancomycin hydrochloride for oral solution is administered for treatment of inflammation of the intestines caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis (inflammation of the inner lining of the large intestine) caused by Clostridioides difficile (C. difficile).

What this means to you:

Adult patients who are prescribed the maximum daily dose of up to 2 grams per day of vancomycin hydrochloride for oral solution, 250 mg/5 mL, may receive up to 4 grams of oral vancomycin per day due to the overfilled bottle. Some patients with inflammatory disorders of the intestines also may have substantial absorption of the vancomycin. These patients may be at risk for adverse effects associated with higher doses of vancomycin. Worsening kidney function could be associated with electrolyte abnormalities such as high potassium leading to cardiac arrest.

Consumers who have Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/mL should examine the bottle, stop using the product if the NDC and lot number is listed on the recall, and contact Amneal via telephone or email for recall information and for product return instructions. Consumers may call Amneal at 1-833-582-0812 Monday through Friday, 8:00 am to 5:00 pm, EST, or email Vancomycin_Recall@amneal.com for further information and instructions on the product return. Consumers should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:

Par is voluntarily recalling one lot of Treprostinil injection 20 mg/20 mL (1 mg/mL) to the consumer level. The product is being recalled due to the potential for silicone particulates in the solution. Treprostinil injection 20 mg/20 mL is supplied in 20 mL multidose vials as sterile solutions in water for injection, individually packaged in cartons under NDC #42023-206-01. Only lot #57014 (expiration date 04/2024) is impacted by this recall. This lot was distributed nationwide to wholesalers and hospitals from June 16, 2022 through October 17, 2022.

Treprostinil injection can be given under the skin or as an intravenous (IV) infusion. The product is a prostacyclin vasodilator FDA-approved for the treatment of pulmonary arterial hypertension (PAH) to decrease symptoms associated with exercise as well as for patients who require transition from epoprostenol to reduce the rate of clinical deterioration.

What this means to you:

Administration of an injectable product that contains particulates may result in local irritation or swelling due to the foreign material. If the particulate reaches the blood vessels, it can travel to various organs and block blood flow in the heart, lungs, or brain which can lead to stroke and could result in death. Consumers should contact their healthcare provider if they have experienced any problems that may be related to using this drug product.

For information regarding the recall process, call Inmar at 1-855-410-3565 Monday through Friday between the hours of 9 am and 5 pm EST. For medical product information or to report a product complaint or adverse event please call 1-800-828-9393.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration.

For or more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:

Brassica is voluntarily recalling certain lots of the following over the counter (OTC) eye ointment products with expiration dates ranging from February 2024 to September 2025: Equate™ Lubricant Eye Ointment (NDC 79903-026-35), Equate Stye™ Lubricant Eye Ointment (NDC 79903-028-35), CVS Health® Lubricant Eye Ointment (NDC 76168-707-35), and Lubricant PM Ointment (NDC 71406-124-35). The lots are being recalled due to lack of sterility assurance that was found during an inspection conducted by the United States (US) Food and Drug Administration (FDA).

For lot recalls, the lot/batch information and expiration date for the recalled product can be viewed by clicking on the link to the FDA Recall Notification found below.

These eye ointment products are for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind and sun. These products may also be used as a protectant against further irritation.

What this means to you:

For those patients who use these recalled products, there is a potential risk of eye infections or similar problems. These products are intended to be sterile. Eye products have a higher risk of harm because drugs applied to the eyes bypass some of the body’s natural defenses.

Consumers should stop using the recalled eye ointment and may return the recalled products to the place of purchase.

Consumers with questions regarding this recall can contact Brassica at 1-833-225-9564 or info@brassicapharma.com. Consumers should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the US FDA.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online at or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:

Azurity is voluntarily recalling 1 lot of Zenzedi® (dextroamphetamine sulfate tablets) 30 mg to the consumer level. The product is being recalled due to a report from a pharmacist who opened a bottle of Zenzedi® 30 mg tablets and found tablets of carbinoxamine maleate, an antihistamine drug. The recalled drug is NDC # 24338-856-03 with lot # F230169A and expiration date June 2025.

Zenzedi® is a prescription medicine FDA-approved for (1) the treatment of narcolepsy and (2) as a treatment for attention deficit hyperactivity disorder (ADHD). The press release linked on the following page provides a description of the appearance of Zenzedi 30 mg tablets and a description of the appearance of carbinoxamine maleate tablets.

What this means to you:

Patients who take carbinoxamine instead of Zenzedi® will experience undertreatment of their symptoms, which may result in impairment and an increased risk of accidents or injury. Patients who consume carbinoxamine could experience side effects such as drowsiness, sleepiness, central nervous system depression, increased eye pressure, enlarged prostate leading to urinary obstruction, and thyroid disorders. For patients with ADHD and narcolepsy, the potential exists for accidents or injuries to occur due to the sedating effects of carbinoxamine. These accidents or injuries could be serious and result in disability or death in severe cases, especially if individuals engage in activities requiring significant focus and alertness, such as driving or operating heavy machinery. To date, Azurity has not received any reports of serious adverse events related to this recall.

Consumers that have product which is being recalled should stop using and return to the place of purchase. Consumers should contact their healthcare provider if they have experienced any problems that may be related to taking this recalled drug. An adverse event may also be reported to Azurity via email at aereports@azurity.com.

For more information regarding this recall, please refer to the following telephone numbers:

For information on the recall process, call Inmar at 877-804-2069 (Monday to Friday, 9 am to 5 pm EST).
For medical information or to report a side effect, call 800-461-7449 (Monday to Friday, 9 am to 5 pm EST).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:

Lupin Pharmaceuticals is voluntarily recalling 4 lots of Quinapril Tablets USP, 20 mg and 40 mg to the patient (consumer/user) level due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level. To date, Lupin has received no reports of illness that appear to relate to this issue.

For lot recalls, the lot/batch information and expiration date for the recalled product can be viewed by clicking on the link to the FDA Recall Notification found below.

What this means to you:

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

Patients taking, Quinapril Tablets USP, 20mg, and 40mg are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.

Wholesalers, distributors and retailers that have Quinapril Tablets USP, 20mg, and 40mg that are being recalled should discontinue distribution of the recalled product lots immediately.

Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (877) 538-8445 Monday – Friday 09:00 am to 05:00 pm EST. For reimbursement, please have the recalled lots returned to Inmar Rx Solutions, Inc.; the lot number can be found on the side of the bottle label.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration. For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:

Mylan Institutional is voluntarily recalling lot AJ21002, exp 3/2024, of Octreotide Acetate Injection, 500 mcg/mL, packaged in a carton of ten 1mL syringes. This lot is being recalled at the user (hospital/pharmacy) level due to a product complaint of the presence of glass particles in a syringe.

For lot recalls, the lot/batch information and expiration date for the recalled product can be viewed by clicking on the link to the FDA Recall Notification found below.

Octreotide Acetate Injection is indicated to reduce blood levels of growth hormone (GH) and insulin growth factor1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. It is also indicated for the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease and for the treatment of the profuse watery diarrhea associated with vasoactive intestinal peptide (VIP)-secreting tumors.

What this means to you:

Intravenous administration of a solution containing particulate matter, such as a glass, could lead to events including, but not limited to, local irritation or swelling, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism. Although the intravenous administration of a solution containing particulate matter may pose potential risk of serious adverse events, the probability of exposure from this incident and subsequent risk is low. To date, no reports of adverse reactions associated with this lot have been received.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration. For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:

Aurobindo Pharma USAhas initiated a voluntary recall of 2 lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg, to the consumer level from the US market due to the presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril above the proposed interim limit. Lot #QE2021005-A and #QE2021010-A.

For lot recalls, the lot/batch information and expiration date for the recalled product can be viewed by clicking on the link to the FDA Recall Notification found below.

Quinapril and Hydrochlorothiazide Tablets, USP are fixed-combination tablets that combine an angiotensinconverting enzyme (ACE) inhibitor, quinapril hydrochloride, and a thiazide diuretic, hydrochlorothiazide. This product is indicated for the treatment of high blood pressure. Patients should contact their doctor or health care provider about whether to continue taking their medication, or whether to consider an alternative treatment prior to returning their medication.

What this means to you:

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Any general questions regarding the return of this product please contact Qualanex at 1-888-504- 2014 (live calls received 7:00 am to 4:00 pm M-F CST).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration. For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:

Golden State Medical Supply- has initiated a voluntary recall of Clopidogrel 75 mg tablets, 1,000 count bottle and Atenolol 25 mg tablets, 1000 count bottle. A report was received that a bottle containing Clopidogrel 75mg Tablets produced with lot# GS046745 was mislabeled as Atenolol 25mg Tablets. This voluntary recall only affects products with lot# GS046745. No other Clopidogrel or Atenolol products marketed by GSMS, Inc. are impacted. Both products are being recalled out of abundance of caution.

For lot recalls, the lot/batch information and expiration date for the recalled product can be viewed by clicking on the link to the FDA Recall Notification found below.

Atenolol tablets are indicated for the treatment of high blood pressure. Clopidogrel is prescribed to lower the risk of having a stroke, blood clot, or serious heart problem for patients who have had heart attack, severe chest pain,or circulation problems as indicated in the product labeling.

What this means to you:

Patients who suddenly stop taking atenolol are at an increased risk for reduced blood flow (chest pain, heart attack), high blood pressure and abnormal heart rhythm adverse events relating to rapid withdrawal of beta antagonism. Further, patients who are on atenolol are frequently on concomitant anticoagulant and antiplatelet medications and would be at increased risk for bleeding if clopidogrel were added to the regimen.

Consumers with questions regarding this recall can contact Golden State Medical Supply by: Phone: (800) 284-8633, ext. 116 (include days between 7:30 AM to 4:00 PM, Pacific).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration. For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:

Vi-Jon is revising a previously reported list of all flavors of Magnesium Citrate Saline Laxative Oral Solution within expiry that were voluntarily recalled to the consumer level to include product that was distributed in the United States, Canada, and Panama. This includes all lots of lemon flavor, cherry flavor, and grape flavor of Magnesium Citrate Saline Laxative Oral Solution, 296 mL within expiry. The recall was initiated after Vi-Jon’s third party microbial testing identified the presence of Gluconacetobacter liquefaciens. The initial recall for 1 lot of lemon flavor was issued in June 2022; this recall was expanded to include all lots of lemon flavor on July 15, 2022 and subsequently all lots all flavors on July 26, 2022. In August 2022, the revised listing of recalled products was issued.

The product names and NDC numbers for the recalled product can be viewed by clicking on the link to the FDA Recall Notification found below.

The product is used for relief of occasional constipation (irregularity) and generally produces a bowel movement in a ½ hour to 6 hours.

What this means to you:

Patients with weakened immune systems (immunocompromised), who consume this product, may be at increased risk for serious infections caused by Gluconacetobacter liquefaciens that could lead to life-threatening health consequences. To date, Vi-Jon is aware of 3 reports of serious side effects potentially related to this recall. Vi-Jon is in the process of investigating these reports. Consumers with questions regarding this recall can contact Vi-Jon by e-mail (Recalls@Vijon.com) or phone call (615) 208-2441, Monday to Friday, from 7:30 am to 4:30 pm, Central Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration. For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:

Mylan Pharmaceuticals is voluntarily recalling 1batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens which are packaged in cartons of five pens to the consumer level. This product is not the branded Semglee® pen but the unbranded Insulin Glargine-yfgn pens, NDC 49502-394-75. This batch is being recalled due to the potential for missing labels on pens For lot recalls, the lot/batch information and expiration date for the recalled product can be viewed by clicking on the link to the FDA Recall Notification found below.

This product is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

What this means to you:

For patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), a missing label on Insulin Glargine pens could lead to a mix-up of products/strengths, which may result in either high or low blood sugar and could lead to serious complications. To date, no adverse events related to this recall have been received for this product.

If you have an unlabeled pen, please contact Sedgwick at 1-877-643-8438 for the documentation packet to return the product.

Consumers with questions regarding this recall can contact Viatris Customer Relations by phone at 1-800-796-9526 or by email at customer.service@viatris.com, Monday through Friday from 8 a.m. – 5 p.m. EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration. For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:

Bryant Ranch Prepack. is voluntarily recalling one lot of Morphine Sulfate 30 mg Extended-Release tablets (comprised of 10 bottles), and one lot of Morphine Sulfate 60 mg Extended-Release tablets (comprised of 10 bottles) to the consumer level listed in the table below. The products have been found to have incorrect labeling. Bottles labeled Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg ExtendedRelease tablets and bottles labeled Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.

For lot recalls, the lot/batch information and expiration date for the recalled product can be viewed by clicking on the link to the FDA Recall Notification found below.

What this means to you:

Morphine Sulfate Extended-Release tablets are used to manage severe pain. The 30 mg tablets are round, purple-colored, film-coated tablets debossed with “RD” and “71” on one side and plain on the other side. The 60 mg 2—0622-2022 Class 1 Morphine Sulfate Extended-Release tablets – Bryan Ranch Prepack Inc Voluntary Recall tablets are round, light orange-colored, film-coated tablets debossed with “RD” and “72” on one side and plain on the other side.

Risk Statement: Patients prescribed the 30 mg dose who receive the 60 mg dose could be at risk for overdose and death. Patients prescribed the 60 mg dose who receive the 30 mg dose may experience withdrawal and untreated pain if the dose given is too low. To date, Bryant Ranch Prepack Inc. has not received any reports of adverse events related to this recall.

Bryant Ranch Prepack is notifying its distributors and customers by email, phone, and letter, and is arranging for return of all recalled products. Consumers/distributors/retailers that have these products which are being recalled should stop using and contact Bryant Ranch Prepack Inc. at: cs@brppharma.com or call 877-885-0882.

Consumers with questions regarding this recall can contact Bryant Ranch Prepack Inc. at 877-885-0882 or cs@brppharma.com, Monday-Friday 7:30am-5:00pm PDT. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration. For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:

Vi-Jon is voluntarily recalling 1 lot of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) to the consumer level. Testing identified the affected lot of the product to contain the bacteria Gluconacetobacter liquefaciens.

For lot recalls, the lot/batch information and expiration date for the recalled product can be viewed by clicking on the link to the FDA Recall Notification found below.

The product is used for relief of occasional constipation (irregularity) and generally produces a bowel movement in 1/2 to 6 hours. The product is packaged in a 10 oz clear round plastic bottle. The affected CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor lot includes the following batch number: 0556808 and expiration date: 12/2023 on the shoulder of the bottle. This lot of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor was sent to a 3rd party outside lab for testing per CVS request as a first production sample for CVS. This lot of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor was distributed Nationwide at CVS drug store locations.

What this means to you:

Immunocompromised patients, who consume this product, may be at increased risk for invasive infections caused by Gluconacetobacter liquefaciens that could lead to serious, life threatening adverse health consequences. To date, ViJon has not received any complaints related to this recall.

Vi-Jon has already notified CVS by phone and email and is arranging for return of all recalled product.

Consumers that have this recalled product should stop using and return any remaining product to the place of purchase.

Consumers with questions regarding this recall can contact Vi-Jon by e-mail Recalls@Vijon.com Monday-Friday, from 7:30 am to 4:30 pm Central Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration. For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:

Teva Pharmaceuticals USA has initiated a voluntary nationwide recall of a single lot of Anagrelide Capsules, USP 0.5 mg (NDC 0172-5241-60), to the consumer level in the United States. This voluntary recall was initiated due to failure of the product to dissolve during routine stability testing. No other lots are impacted.

For lot recalls, the lot/batch information and expiration date for the recalled product can be viewed by clicking on the link to the FDA Recall Notification found below.

Anagrelide capsules are indicated for the treatment of patients with high platelet counts, secondary to certain cancers, to reduce the elevated platelet count and the risk of blood clots and to prevent associated symptoms including clotting/bleeding events.

What this means to you:

If the drug does not dissolve it can lead to less anagrelide available in the body. For seriously ill patients with elevated platelet counts, less available anagrelide in the body could increase the risk of clotting (blood coagulation) and bleeding events such as a heart attack or stroke, which could be life-threatening. To date, Teva has not received any product quality complaints or adverse event reports for the recalled lot.

According to the manufacturer, as a patient, your first course of action should be to consult with your pharmacist, healthcare provider, or physician who can advise you about an alternative treatment prior to discontinuation of the medication.

The risks from stopping the medication may be higher than the potential risk of continuing anagrelide treatment for a short period of time. Once your pharmacist, healthcare provider, or physician has provided an alternate medication to treat the condition, the manufacturer requests that you return any remaining product in your possession. Please contact Teva’s product recall processor to obtain instructions and a kit for returning your medication: Inmar (866-431-5972 – Dedicated Phone Line) or email Inmar at rxrecalls@inmar.com.

Inmar will provide the materials that you will need to return your medication, which will include a pre-paid mailer and instructions for your reimbursement.

Consumers with questions or concerns should first consult with their health care provider(s). To report an Adverse Event or Quality Complaint, or if you have Medical Related Questions, please use the following contact information:

Medical-related Questions or to report an Adverse Event:
Contact Medical Information at: 888-838-2872, option 3, then, option 4
Live calls received: M – F, 9:00 AM – 5:00 PM Eastern Time, Voicemail: 24 hrs./day, 7 days/week 24 hrs. /day, 7 days/week, or by email at druginfo@tevapharm.com.

Product Quality Complaint-related Questions:

Contact Quality Assurance Services: 888-838-2872, option 4
Live calls received: M – F, 9:00 AM – 5:00 PM Eastern Time; Voicemail: 24 hrs./day, 7 days/week.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration. For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

Teva Pharmaceuticals USA has initiated a voluntary nationwide recall of a single lot of Anagrelide Capsules, USP 0.5 mg (Lot number GD01090), to the consumer level in the United States. This voluntary recall was initiated due to a dissolution test failure detected during routine stability testing. No other lots are impacted.

Administration of this product with lower dissolution – taking longer to dissolve once ingested — may result in decreased effectiveness or ineffectiveness of the drug to exert its platelet-reducing effect. Failed dissolution can result in a slower rate and extent of drug release leading to less anagrelide available in the body. For seriously ill patients with elevated platelet counts, less available anagrelide in the body could increase the risk of clotting (blood coagulation), and clotting or bleeding events such as a heart attack or stroke, which could be life-threatening. To date, Teva has not received any product quality complaints or adverse event reports, of this nature, for the recalled lot.

Anagrelide capsules are indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. Information about the affected lot is listed in the table below. It is packed in bottles with 100 capsules. Teva distributed 4,224 bottles nationwide from 07-30-2020 through 09-02-2020 to its wholesale, distributor, and retail customers under the label for Teva Pharmaceuticals USA, Inc.

NDC	Lot #	Exp. Date
0172-5241-60	GD01090	05/2022

Teva notified its customers on May 11, 2022, alerting them that the lot was recalled and requesting that they return impacted product. Instructions for returning recalled product and receiving a credit are given in the customer recall letter (Anagrelide Recall 05 2022 Direct Accounts Letter Consumer Level 20 MAY 2022.pdf) and consumer recall letter (Anagrelide Recall 05 2022 _Patient Letter 20 MAY 2022.pdf) released by Teva.

Product Quality Complaint-related Questions:
Contact Quality Assurance Services: 888-838-2872, option 4
Live calls received: M – F, 9:00 AM – 5:00 PM Eastern Time; Voicemail: 24 hrs./day, 7 days/week.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

This recall communication is from the FDA.

Company Contact Information

Consumers:
888-838-2872, option 4
druginfo@tevapharm.com

Media:
Kelley Dougherty
973-658-0237

Product Photos:
Click here for product photos

About this recall:

Pfizer is voluntarily recalling five (5) lots of Accupril (quinapril HCl) tablets distributed by Pfizer to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level.

Accupril is indicated for the treatment of hypertension, to lower blood pressure. Accupril is also indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digoxin. To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall.

What this means to you:
Nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time. Although long-term ingestion of N nitroso quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication. Patients currently taking the products should consult with their doctor or healthcare provider about alternative treatment options for them.

The NDC, lot number, expiration date, configuration details, and photos for the recalled products are available at the FDA Recall Notification link on the following page.

Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product. Patients with the affected product should contact Sedgwick at 888-345-0481 (Mon.-Fri. 8:00 am – 5:00 pm ET) for instructions on how to return their product and obtain reimbursement for their cost.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration. For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:

Pfizer is voluntarily recalling five (5) lots of Accupril (Quinapril hydrochloride [HCl]) tablets distributed by Pfizer to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level.

Accupril is indicated for the treatment of hypertension, to lower blood pressure. Accupril is also indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digoxin. Accupril has a safety profile that has been established over 30 years. To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall. Pfizer believes the benefit/risk profile of the products remains positive based on currently available data. Although long-term ingestion of N-nitroso quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication. Patients currently taking the products should consult with their doctor or health care provider about alternative treatment options for them.

The NDC, Lot Number, Expiration Date, and Configuration details for these products are indicated in the tables

below, and photos of the products are linked at the end of this press release. The product lots were distributed nationwide to wholesalers and distributors in the United States (US) and Puerto Rico from December 2019 to April 2022.

Table 1. Accupril^®(Quinapril HCl Tablets), 10 mg, 20 mg, and 40 mg

NDC	Lot number	Expiration Date	Strength	Configuration/Count
00071-0530-23	DR9639	2023 MAR 31	10 mg	1 x 90 count bottle
00071-0532-23	DX8682	2023 MAR 31	20 mg	1 x 90 count bottle
00071-0532-23	DG1188	2022 MAY 31	20 mg	1 x 90 count bottle
00071-0535-233	DX6031	2023 MAR 31	40 mg	1 x 90 count bottle
00071-0535-233	CK6260	2022 MAY 31	40 mg	1 x 90 count bottle

Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified direct consignees by letter to arrange for return of any recalled product.

Wholesalers and distributors with an existing inventory of the lots, listed in the table above, should stop use and distribution and quarantine the product immediately.

If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Please conduct a sub-recall to those accounts and communicate this recall information immediately. Please request they immediately cease distribution of the affected product and promptly contact Sedgwick at 888-345-0481 (Mon.-Fri. 8:00 am – 5:00 pm ET) to obtain a Business Reply Form (BRF) to initiate the return process.

If you received free product through the Pfizer Patient Assistance Program (PAP) or the Pfizer Institutional Patient Assistance Program (IPAP), please check your stock immediately against the table above. If you have any of the affected product lots in your inventory, please follow the instructions above for returning the product to Sedgwick.

Additionally, if you are aware of any patients to whom you dispensed the affected lots who still may have the product in their possession, please ask them to return the product to you and then follow the instructions above for returning the product to Sedgwick. To request replacement product for any Pfizer PAP or Pfizer IPAP product you return, please contact 833-203-2776 (Mon.-Fri. 8 am-6 pm ET).

Healthcare professionals with questions regarding this recall can contact Pfizer using the below information.

Pfizer Medical Information
Medical questions regarding the product 800-438-1985, option 3, (Mon.- Fri. 8 am-9 pm ET)
www.pfizermedinfo.com

Pfizer Drug Safety

Report adverse events and product complaints 800-438-1985, option 1, (24 hours a day; 7 days a week)

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

This recall communication is from the FDA.

Company Contact Information

Consumers:
Sedgwick
888-345-0481

Media:
+1 (212) 733-7410
PfizerMediaRelations@pfizer.com

Product Photos
Click here for product photos.

About this recall:

Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its Insulin Glargine (Insulin glargine- yfgn) Injection, 100 units/mL (U-100), which is packaged in a 10 mL vial that is inside a carton. This product is not the branded Semglee vial but the unbranded Insulin Glargine- yfgn vial. This batch is being recalled due to the potential for the label to be missing on some vials.

What this means to you:

For patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), a missing label on Insulin Glargine vials could lead to a mix-up of products/strengths, which may result in less optimal glycemic control (either high or low blood sugar) which could result in serious complications. To date, no adverse events related to this recall have been received for this product.

The product is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

If you have an unlabeled product, please contact Stericycle at 1-888-912-7084 for the documentation packet to return product to Stericycle. Consumers with questions regarding this recall can contact Viatris Customer Relations by 1-800-796-9526 or customer.service@viatris.com, Monday through Friday from 8 a.m. – 5 p.m. EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration. For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:

Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), which is packaged in a 10 mL vial that is inside a carton. This product is not the branded Semglee vial but the unbranded Insulin Glargine-yfgn vial. This batch is being recalled due to the potential for the label to be missing on some vials. The product information, batch number and expiry date information are present on the carton.

This batch was manufactured by Biocon Sdn. Bhd. and was distributed by Mylan Specialty L.P. in the US between December 9, 2021, and March 4, 2022. The recalled batch is as follows:

NDC #	Name and Strength	Size	Batch #	Expiry
49502-0393-80	Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100)	10 ML vial	BF21002800	August 2023

Risk Statement: For patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), a missing label on Insulin Glargine vials could lead to a mix-up of products/strengths, which may result in less optimal glycemic control (either high or low blood sugar) which could result in serious complications. To date, no adverse events related to this recall have been received for this product.

This recall does not pertain to the branded interchangeable biosimilar, Semglee® (insulin glargine-yfgn) injection but to the unbranded interchangeable biosimilar Insulin Glargine-yfgn vial.

The product is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. The company has initiated the 2—0412-2022 Class 1 Insulin Glargine – Mylan Voluntary Recallrecall of batch BF21002800 and notified its distributors and retailers by letter and is arranging for return of all recalled products. Following are actions for wholesalers, retailers, and consumers:

Wholesaler: Immediately examine your inventory, quarantine, and discontinue distribution of the batchsubject to recall. In addition, if you have further distributed the product, please identify all customers, including retail level customers, and provide a list of customers via Microsoft excel file mylan5889@sedgwick.com within 5 business days. Sedgwick will notify your retail level customers that received the affected batch.
Retailer: Immediately examine your inventory, quarantine, and discontinue distribution of this batch.
Consumer: If you have an unlabeled product, please contact Sedgwick at 1-888-912-7084 for the
documentation packet to return product to Sedgwick.

Consumers with questions regarding this recall can contact Viatris Customer Relations by 1-800-796-9526 or customer.service@viatris.com, Monday through Friday from 8 a.m. – 5 p.m. EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

This recall communication is from the FDA.

Company Contact Information

Consumers:
Viatris Customer Relations
1-800-796-9526
customer.service@viatris.com

Media:
Jennifer Mauer
+1-724-514-1968
Jennifer.Mauer@viatris.com

Product Photos
Click here for product photos

About this recall:

Adamis is voluntarily recalling certain lots of Symjepi (epinephrine) Injection 0.15 mg (0.15 mg/0.3 mL) and 0.3 mg (0.3 mg/0.3 mL) prefilled single-dose syringes to the consumer level. The batches (lots) in the table on the following page are being recalled due to the potential clogging of the needle preventing the dispensing of epinephrine. US WorldMeds (USWM) exclusively markets and distributes Symjepi in the United States (US), under license from Adamis.

Drug recalled (manufacturer): Symjepi (Adamis Pharmaceuticals)

NDCs impacted: 78670-0131-02, 78670-0130-02

What this means to you:

If a person is experiencing an allergic reaction and/or anaphylaxis and is unable to access life-saving epinephrine due to the syringe malfunction, it can lead to life threatening consequences including death. Although not confirmed to be related to the recall, there have been two different customer complaints on three syringes, regarding difficulty in dispensing the product, to date. However, neither US WorldMeds nor Adamis Pharmaceuticals has received, or is aware of, any adverse events related to this recall.

Symjepi is used for the emergency treatment of allergic reactions including anaphylaxis to stinging insects (bees, wasps, hornets, yellow jackets, and fire ants) and biting insects (mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances and other allergens, as well as anaphylaxis of unknown cause and exercise-induced anaphylaxis.

The products are packaged in 2-count prefilled single-dose syringes per carton and were distributed nationwide in the US. The products can be identified by the label containing the US WorldMeds name and logo pictured on the cartons linked on the following page at the FDA Recall Notification and by the NDCs, lot numbers, and expiration dates shown in the table on the following page.

Consumers that have products that are subject to this recall should stop using the products immediately and may either return or discard the recalled lots. Consumers with questions regarding this recall can call (888) 900-8796 or e-mail questions at medinfo@usworldmeds.com Monday through Friday from 8:00 am to 4:00 pm ET.

The recall encompasses all of the following batches, within expiry:

Annual Wholesaler Acquisition Cost (WAC)

Drug Name	Indication	WAC	Annual Cost
Drug 1	Cancer Type A	$50,000	$600,000
Drug 2	Cancer Type B	$45,000	$540,000

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:
Adamis Pharmaceuticals Corporation is voluntarily recalling certain lots of Symjepi (epinephrine) Injection (0.15 mg/0.3 mL) and 0.3 mg (0.3 mg/0.3 mL) prefilled single-dose syringes to the consumer level. The batches in the table below are being recalled due to the potential clogging of the needle preventing the dispensing of epinephrine. US WorldMeds (USWM) exclusively markets and distributes Symjepi in the United States (US), under license from Adamis, the New Drug Application (NDA) holder. USWM will handle the entire recall process for Adamis, with Adamis oversight. Symjepi is manufactured and tested for Adamis by Catalent Belgium S.A.

Risk Statement: If a person is experiencing an allergic reaction and/or anaphylaxis and is unable to access lifesaving epinephrine due to the syringe malfunction, it can lead to life threatening consequences including death. Although not confirmed to be related to the recall, there have been two different customer complaints on three syringes, regarding difficulty in dispensing the product, to date. However, neither US WorldMeds nor Adamis Pharmaceuticals has received, or is aware of, any adverse events related to this recall.

The recall encompasses all of the following batches, within expiry:

Product: Symjepi (epinephrine) Injection Strengeth: 0.15 mg/0.3 mL | 0.3 mg/0.3 mL NDC: 78670-0131-02 | 8670-0130-02
Lot: 21101Y | 1041W | 21081W | 21102W
Expiration: 11/30/2022 | 8/31/2022 | 11/30/2022 | 2/28/2023

Symjepi is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets, and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.

The products are packaged in 2-count prefilled single-dose syringes per carton and were distributed nationwide in the US and directly to customers and/or medical facilities. The products can be identified by the label containing the US WorldMeds name and logo pictured on the cartons below.

US WorldMeds is notifying its customers by email, FDA alerts, and direct outreach. Consumers and institutions that have products that are subject to this recall should stop using the products immediately and may either return or discard the recalled lots. Consumers with questions regarding this recall can call (888) 900-8796 or e-mail questions at medinfo@usworldmeds.com Monday through Friday from 8:00 am to 4:00 pm ET.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

This recall communication is from the FDA.

Company Contact Information
Adamis Contacts

Quality Compliance:
Craig Stenland -Quality Compliance Partners
858-361-6456
craigs@qualpartners.com

Investor Relations:
Robert Uhl- Managing Director
ICR Westwicke
619.228.5886
robert.uhl@westwicke.com

Consumers:
(888) 900-8796
medinfo@usworldmeds.com

Product Photos
Click here for product photos

About this recall:

Pfizer is voluntarily recalling Accuretic (quinapril HCl/hydrochlorothiazide) tablets distributed by Pfizer as well as authorized generics distributed by Greenstone (quinapril HCl/HCTZ tablets) to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-quinapril, above the acceptable daily intake level. Pfizer has recalled six lots of Accuretic tablets and five lots of quinapril HCl/HCTZ tablets.

What this means to you:

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

Accuretic and quinapril HCl/HCTZ are indicated for the treatment of high blood pressure. Lowering blood pressure reduces the risk of cardiovascular events, primarily strokes and heart attacks. To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall. Although long term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication. Patients currently taking the products should consult with their doctor about alternative treatment options.

The NDCs, lot numbers, and expiration dates for the recalled products are provided in the FDA Recall
Notification, linked on the following page. Photos of the products are also available at the FDA Recall Notification.

Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product. Patients with the recalled product should contact Sedgwick at 888-843-0247 (Monday through Friday 8:00 am to 5:00 pm ET) for instructions on how to return their product and obtain reimbursement for their cost.

Healthcare Professionals with questions regarding this recall can contact Pfizer using the below information.

Contact Center	Contact Info	Area of Support
Pfizer Medical Information	800-438-1985, option 3 (Monday-Friday 8am-9pm EST)	For medical questions regarding the product
Pfizer Drug Safety	800-438-1985, option 1	To report adverse events and product complaints

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:
Pfizer is voluntarily recalling Accuretic (quinapril hydrochloride [HCl]/hydrochlorothiazide [HCTZ]) tablets distributed by Pfizer as well as authorized generics distributed by Greenstone (quinapril HCl/HCTZ) to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-quinapril, above the acceptable daily intake (ADI) level. Pfizer has recalled six lots of Accuretic tablets and five lots of quinapril HCl/HCTZ tablets.

These products are indicated for the treatment of hypertension. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. The products have a safety profile that has been established over 20 years of marketing authorization and through a robust clinical program. To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall. Pfizer believes the benefit/risk profile of the products remains positive based on currently available data. Although long term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication. Patients currently taking the products should consult with their doctor about alternative treatment options.

The NDC, Lot Number, Expiration Date, and Configuration details for these products are indicated in the tables below and photos of the products can be found at the end of this press release. The product lots were distributed
nationwide to wholesalers and Distributors in the United States and Puerto Rico from November 2019 to March 2022.

Table 1. Six recalled Accuretic (quinapril HCl/hydrochlorothiazide) lots in 90-count bottles

NDC	Lot Number	Expiration Date	Strength
00071-3112-23	FG5379	08/2024	10/12.5 mg
00071-0222-23	EA6686	04/2022	10/12.5 mg
00071-5212-23	FG5381	08/2024	20/12.5 mg
00071-0220-23	EA6665	04/2022	20/12.5 mg
00071-0220-23	CN0640	04/2022	20/12.5 mg
00071-0223-23	ET6974	02/2023	20/25 mg

Table 2. Five recalled quinapril HCl/HCTZ lots in 90-count bottles

NDC	Lot Number	Expiration Date	Strength
59762-5225-09	FE3714	02/2023	20/25 mg
59762-0220-01	DN6931	03/2023	20/12.5 mg
59762-0220-01	ED3904	03/2023	20/12.5 mg
59762-0220-01	ED3905	03/2023	20/12.5 mg
59762-0223-01	DP3414	02/2023	20/25 mg

Wholesalers and distributors with an existing inventory of the lots, listed in the table above, should stop use and distribution and quarantine the product immediately. If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Please conduct a sub-recall to those accounts and communicate this recall information immediately.

Please request they immediately cease distribution of the affected product and promptly contact Sedgwick at 888-843-0247 (Monday through Friday 8:00 am – 5:00 pm ET) to obtain a Business Reply Card (BRC) to initiate the return process.

Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product. Patients with the affected product should contact Sedgwick at 888-843-0247 (Mon.-Fri. 8:00 am – 5:00 pm ET) for instructions on how to return their product and obtain reimbursement for their cost.

Healthcare Professionals with questions regarding this recall can contact Pfizer using the below information.

Contact Center	Contact Information	Area of Support
Pfizer Medical Info	800-438-1985, option 3 (Monday-Friday 8am-9pm EST)	For medical questions regarding the product
Pfizer Drug Safety	800-438-1985, option 1	To report adverse events and product complaints

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

This recall communication is from the FDA.

Company Contact Information

Consumers:
Sedgwick
888-843-0247

Media:
Media Relations
+1 (212) 733-7410
PfizerMediaRelations@pfizer.com

Product Photos
Click here for product photos

About this recall:
Sandoz Inc. (“Sandoz”) is initiating a voluntary recall of 13 lots of oral Orphenadrine Citrate 100 mg Extended Release (ER) Tablets to the consumer level. The presence of a nitrosamine impurity, which has the potential to be above the U.S. Food and Drug Administration (FDA)’s Acceptable Daily Intake (ADI) limit of 26.5 ng/day, was detected in the lots during recent testing. These 13 lots of Orphenadrine Citrate ER Tablets were shipped to customers from August 2019 to April 2021.

What this means to you:
Nitrosamines are substances that could cause cancer when present above the allowable exposure limits. While the use of products belonging to the recalled lots may represent a risk to patients, to date, Sandoz has not received any reports of adverse events related to the presence of a nitrosamine impurity in the lots. Orphenadrine Citrate ER Tablets are used as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.

Consumers who have Orphenadrine Citrate ER Tablets being recalled should stop taking the recalled product and immediately consult with their physician to obtain another prescription. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Consumers should contact Sedgwick by phone at 844-491-7869 Monday – Friday, 8:00 am – 5:00 pm EST, or email at sandoz4887@sedgwick.com to return the recalled product.

This recall of Orphenadrine Citrate ER Tablets is specific to the lots listed at the link on the following page and does not apply to any other strengths of Sandoz Orphenadrine Citrate ER Tablets nor to other lot numbers of the product.

To report an adverse reaction, please contact Sandoz by phone at (800) 525-8747 or by email at qa.drugsafety@sandoz.com. Customer service agents are available Monday – Friday from 8:30 am to 5:00 pm ET.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:
Sandoz Inc. (“Sandoz”) is initiating a voluntary recall of 13 lots (listed below) of oral Orphenadrine Citrate 100 mg Extended Release (ER) Tablets to the consumer level. The presence of a nitrosamine (N-methyl-N-nitroso-2-[(2- methylphenyl)phenylmethoxy]ethanamine (NMOA or Nitroso-Orphenadrine)) impurity, which has the potential to be above the U.S. Food and Drug Administration (FDA)’s Acceptable Daily Intake (ADI) limit of 26.5 ng/day, was detected in the lots during recent testing. These 13 lots of Orphenadrine Citrate ER Tablets were shipped to customers from August 2019 to April 2021.

Nitrosamines are substances with carcinogenic potential (substances that could cause cancer) when present above the allowable exposure limits. While the use of product belonging to the recalled lots may represent a risk to patients, to date, Sandoz has not received any reports of adverse events related to the presence of a nitrosamine impurity in the lot.

Orphenadrine Citrate ER Tablets are used as an adjunct to rest, physical therapy and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. The product is packaged in 100-count and 1000-count bottles and was distributed nationwide in the USA to wholesalers and distributors.

This recall of Orphenadrine Citrate ER Tablets is specific to the lots listed below and does not apply to any other strengths of Sandoz Orphenadrine Citrate ER Tablets nor to other lot numbers of the product. Any product returned that is not associated with this recall will be destroyed, and no credit will be issued.

Sandoz is notifying its wholesalers and distributors by mail and is arranging for the return of all recalled product. Wholesalers and distributors that have Orphenadrine Citrate ER Tablets subject to this recall should immediately stop distribution of the recalled product and quarantine and return all recalled product in their inventory.

Consumers who have Orphenadrine Citrate ER Tablets being recalled should stop taking the recalled product and immediately consult with their physician to obtain another prescription. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Table 1. Recalled Lots of Orphenadrine Citrate ER Tablets

NDC Number	Lot Number	Expiration Date	Date of Manufacturer
0185-0022-01	JX6411	05/2022	5/24/2019
0185-0022-01	JX6413	05/2022	5/24/2019
0185-0022-01	KC0723	08/2022	8/21/2019
0185-0022-01	KE4348	11/2022	8/21/2019
0185-0022-01	KE7169	11/2022	8/21/2019
0185-0022-01	KE4349	11/2022	8/21/2019
0185-0022-01	KL3199	03/2023	3/3/2020
0185-0022-01	KM0072	03/2023	3/3/2020
0185-0022-01	LA7704	10/2023	10/6/2020
0185-0022-01	LA7703	10/2023	10/6/2020
0185-0022-01	LA9243	11/2023	10/6/2020
0185-0022-10 + 1,00 count bottle	KS3939	03/2023	3/3/2020

Retailers and consumers should contact Sedgwick directly by phone at 844-491-7869 or email at sandoz4887@sedgwick.com to return the recalled product. Representatives are available Monday – Friday, 8:00 am – 5:00 pm ET.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

This recall communication is from the FDA.

Company Contact Information

Consumers:
Sedgwick
844-491-7869
sandoz4887@sedgwick.com

Media:
Leslie Pott
201-354-0279

About this recall:
Mylan is voluntarily recalling 1 batch of its non-interchangeable Semglee® (insulin glargine injection), 100 units/mL (U-100), 3 mL prefilled pens, which are packaged in a labeled carton of 5 pens (NDC 49502-0196-75). The product is being recalled due to the potential for the label to be missing on some prefilled pens within a labeled carton for this particular batch. The recalled batch number is BF20003118 with an expiration date of August 2022.

What this means to you:
A missing label on Semglee prefilled pens, for patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), could lead to a mix-up of products/strengths, resulting in administration of the wrong insulin. Administration of the wrong insulin could result in either high or low blood sugar which could lead to serious complications. To date, the company has not received any reports of adverse events related to this recall.

This recall does not pertain to the recently launched interchangeable biosimilar, Semglee® (insulin glargineyfgn) injection or Insulin Glargine (insulin glargine-yfgn) injection. The product is a long-acting human insulin analog indicated to improve blood glucose control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. It is packaged in prefilled pens in cartons of 5 pens. The recalled product can be identified by the prefilled pens missing a white label with the product name and dosage information affixed around the pen. The company has initiated the recall of batch BF20003118 and is arranging for return of all recalled products.

Consumer: If you have an unlabeled product, please contact Stericycle at 1-888-843-0255 for the documentation packet to return the product to Stericycle.

Consumers with questions regarding this recall can contact Viatris Customer Relations by 800-796-9526
or customer.service@viatris.com, Monday through Friday from 8 am to 5 pm EST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s
MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:
Mylan is voluntarily recalling 1 batch of its non-interchangeable Semglee® (insulin glargine injection), 100 units/m (U-100), 3 mL prefilled pens, which are packaged in a labeled carton of 5 pens. The product is being recalled due to the potential for the label to be missing on some prefilled pens within a labeled carton for this particular batch.

This batch was manufactured by Biocon Sdn Bhd. and distributed by Mylan Specialty in the United States (US) between May 11, 2021 and November 11, 2021.

NDC	Name and Strength	Size	Batch Number
49502-0196-75	Semglee® (insulin glargine injection) 100 units/mL (U-100)	3 mL prefilled pen	BF20003118

Risk Statement: A missing label on Semglee prefilled pens, for patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), could lead to a mix-up of products/strengths, resulting in administration of the wrong insulin. Administration of the wrong insulin could result in less optimal glycemic control (either high or low blood sugar) which could lead to serious complications. To date, the company has not received any reports of adverse events related to this recall.

This recall does not pertain to the recently launched interchangeable biosimilar, Semglee® (insulin glargineyfgn) injection, a branded product, or Insulin Glargine (insulin glargine-yfgn) injection, an unbranded product.

The product is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. It is packaged in prefilled pens in cartons of 5 pens. The recalled product can be identified by prefilled pens missing a white label with the product name and dosage information affixed around the pen.

The company has initiated the recall of batch BF20003118 and notified its distributors and retailers by letter and is arranging for return of all recalled products. Following are actions for wholesalers, retailers, and consumers:

Wholesaler: Immediately examine your inventory, quarantine, and discontinue distribution of this lot. In addition, if you have further distributed the product, please identify your retail level customers and provide a list of customers via Microsoft excel file to mylan6069@sedgwick.com within 10 business days. Stericycle will notify your retail level customers that received the affected batch.
Retailer: Immediately examine your inventory, quarantine, and discontinue distribution of this batch.
Consumer: If you have an unlabeled product, please contact Stericycle at 1-888-843-0255 for the documentation packet to return product to Stericycle.

Consumers with questions regarding this recall can contact Viatris Customer Relations by 800-796-9526 or customer.service@viatris.com, Monday through Friday from 8 am to 5 pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this
drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the US Food and Drug Administration.

Link to FDA recall notification

Product Photos:

Click here for product photos

About this recall:
Viona is voluntarily recalling twenty-three (23) lots of Metformin HCl ER Tablets, USP 750 mg at the consumer level due to the detection of the NDMA impurity. The reason for the recall is an out of specification result found for one (1) lot of the product’s long-term stability samples. In an abundance of caution, the firm has decided to voluntarily recall 23 batches which they have determined having a valid shelf life within the United States (US) market. This product was manufactured by Cadila Healthcare Limited, India for US distribution by Viona Pharmaceuticals.

What this means to you:
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods, including meats, dairy products, and vegetables. Patients who have received impacted lots of Metformin HCl ER Tablets, USP 750mg are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment. According to the FDA, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their healthcare professionals (HCPs). Please visit the agency’s website for more information. To date, neither Viona nor Cadila have received any reports of adverse events related to this recall.

The product is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in plastic bottles of 100 tablets, under NDC 72578-0036-01.

The recalled lots of Metformin HCl ER Tablets, USP 750 mg are listed at the link on the following page. The product can be identified as white to off-white, capsule shaped, uncoated tablets, debossed with “Z”, “C” on one side and “20” on the other side. The tablets were distributed nationwide to distributors.

Consumers with questions regarding this recall can contact the recall processor, Inmar Pharmaceutical Services, by phone at 1-855-249-3303, option 1; Monday through Friday (excluding holidays), 9 am to 5 pm, EST.

Consumers should contact their physician or HCP if they have experienced any problems that may be related to taking or using this drug product.

Viona is notifying its customers by email and mail (FedEx Overnight) and is arranging for the return of all recalle products to our recall processor at the following address:

Inmar Pharmaceuticals Services-Recalls
3845 Grand Lakes Way,
Grand Prairie, Texas 75050

Customers with medical-related questions, who wish to report an adverse event, or quality issues about the products being recalled should contact Viona by phone at 888-304-5011, Monday through Friday, 8:30 am to 5:30 pm, EST.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:

Viona is voluntarily recalling twenty-three (23) lots of Metformin Hydrochloride (HCl) Extended-Release (ER) Tablets, USP 750 mg at the consumer level. The reason for the recall is an out-of-specification result observed for one lot of the product (M008132) “NDMA (by GC- MS/MS)” test at 17 months, 25°C/60%RH long-term stability samples. In an abundance of caution, the firm has decided to voluntarily recall 23 batches which they have determined to have a valid shelf life within the United States (US) market. This product was manufactured by Cadila Healthcare Limited, Ahmedabad, India for US distribution by Viona Pharmaceuticals Inc.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods, including meats, dairy products, and vegetables. Patients who have received impacted lots of Metformin HCl ER Tablets, USP 750 mg are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment. According to the FDA, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their healthcare professionals (HCPs). Please visit
the agency’s website for more information. To date, neither Viona nor Cadila have received any reports of adverse events related to this recall.

The product is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in high-density polyethylene (plastic) bottles of 100 tablets, under NDC 72578-0036-01. The recalled lots of Metformin HCl ER Tablets, USP 750 mg are listed in the table on the following page.

The product can be identified as white to off-white, capsule-shaped, uncoated tablets, debossed with “Z”, “C” on one side, and “20” on the other side. The tablets were distributed nationwide to distributors.

Consumers with questions regarding this recall can contact the recall processor, Inmar Pharmaceutical Services, by phone at 1-855-249-3303, option 1; Monday through Friday (excluding holidays), 9 am to 5 pm, EST.

Consumers should contact their physician or HCP if they have experienced any problems that may be related to taking or using this drug product.

Metformin HCl ER Tablets, USP 750 mg

NDC	Batch Number	Expiration Number
72578-0036-01	M008130	06/2022
72578-0036-01	M008131	06/2022
72578-0036-01	M008132	06/2022
72578-0036-01	M008133	06/2022
72578-0036-01	M010080	07/2022
72578-0036-01	M010081	07/2022
72578-0036-01	M011029	08/2022
72578-0036-01	M011030	08/2022
72578-0036-01	M011031	08/2022
72578-0036-01	M011032	08/2022
72578-0036-01	M011033	08/2022
72578-0036-01	M011304	08/2022
72578-0036-01	M013394	09/2022
72578-0036-01	M013395	09/2022
72578-0036-01	M013396	09/2022
72578-0036-01	M013966	09/2022
72578-0036-01	M013967	09/2022
72578-0036-01	M100831	12/2022
72578-0036-01	M100832	12/2022
72578-0036-01	M100833	01/2023
72578-0036-01	M100834	01/2023
72578-0036-01	M101267	01/2023
72578-0036-01	M102718	01/2023
72578-0036-01	M102719	01/2023

Customers with medical-related questions, who wish to report an adverse event, or quality issues about the products being recalled should contact Viona by phone at 888-304-5011, Monday through Friday, 8:30 am to 5:30 pm, EST.

Viona is notifying its customers by email and mail (FedEx Overnight) and is arranging for the return of all recalled products to our recall processor at the following address:

Inmar Pharmaceuticals Services-Recalls
3845 Grand Lakes Way,
Grand Prairie, Texas 75050

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the US Food and Drug Administration.

Link to FDA recall notification

Product Photos
Click here for product photos

About this recall:
Lohxa is voluntarily recalling one lot of Senna Syrup 8.8 mg/5 mL, unit-dose cups to the consumer level. The product is being recalled due to microbial contamination.

What this means to you:

Use of contaminated product by the elderly, patients with a weakened immune system, or patients at a higher risk of developing life-threatening inflammation of the heart, could lead to infections that are life-threatening. To date, Lohxa has not received any reports of adverse events related to this recall.

The product is used as a natural vegetable laxative for the relief of occasional constipation and is packaged into 5 mL unit-dose cups. The product is distributed into cases of 20 cartons packaged with 24 units each, NDC: 50268-0731-24. The affected Senna Syrup 8.8 mg/5 mL lot is AM1115S with expiration date of 01/2023. The product can be identified by the label shown at the FDA website linked on the following page. Product was distributed to AvKare (wholesaler) who may have further distributed this to clinics, hospitals, and healthcare providers.

Lohxa is notifying its distributors and customers by letter and is arranging for return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using the product and return it to place of purchase.

Consumers with questions regarding this recall can contact Lohxa by 800-641-5564 or by email to info@lohxa.com Monday to Friday from 9 am to 5 pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:
Lohxa LLC is voluntarily recalling one lot of Senna Syrup 8.8 mg/5 mL, unit-dose cups to the consumer level. The product is being recalled due to microbial contamination.

The product is used as a natural vegetable laxative for the relief of occasional constipation and is packaged into 5 mL unit-dose cups. The product is distributed into cases of 20 cartons packaged with 24 units each, NDC: 50268-0731-24. The affected Senna Syrup 8.8 mg/5 mL lot is AM1115S with expiration date of 01/2023. The product can be identified by the label shown in the product photos linked on the following page. Product was distributed to AvKare (wholesaler) who may have further distributed this to clinics, hospitals, and healthcare providers.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration (FDA).

Company Contact Information
Consumers: Lohxa LLC

800-641-5564
info@lohxa.com

Product Photos

Click here for product photos.

About this recall:

Taro is voluntarily recalling one (1) lot of Clobetasol Propionate Ointment USP, 0.05% packaged in 60 gram tubes, to the consumer level. The product is being recalled due to microbial contamination. This recall only applies to tubes labeled with “Lot AC13786” and “Exp Dec 2022.”

What this means to you:

This lot is being recalled due to the presence of Ralstonia pickettii bacteria (R. pickettii), which was discovered by the manufacturer through routine testing. R. pickettii is present in the natural environment (soil, water) and for healthy individuals with intact skin, is unlikely to cause any localized or systemic infections. However, for individuals who are immunocompromised or whose skin is not intact (sunburn, psoriasis, abrasions), the potential exists that systemic infections may occur if the product is contaminated with R. pickettii. This is due to the presence of the steroid component which increases absorption of the ointment. If this bacterium circulates in the human blood stream it can cause life-threatening, invasive infections such sepsis, pneumonia, meningitis, inflammation of the bone or bone marrow, and infection in the joint fluid and joint tissues. To date, Taro has not received any adverse event reports related to this lot.

The product is used for the relief of inflammation and itching of the skin that is responsive to steroids. It is packaged in 60 gram aluminum tubes labeled with the name of the product, Clobetasol Propionate Ointment USP, 0.05% and the NDC # 51672-1259-03 (image of container label hyperlinked on the following page). The lot number and expiration date are displayed on the bottom of each tube and the end flap of the product carton.

Consumers with questions regarding this recall can contact Taro by calling 1-866-923-4914 or by e-mail at TaroPVUS@taro.com, Monday through Friday between 7 am and 7 pm, US Central Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:

Taro Pharmaceuticals is voluntarily recalling one (1) lot of Clobetasol Propionate Ointment USP, 0.05% packaged in 60 g tubes to the consumer level. This recall ONLY applies to tubes labeled with “Lot AC13786” and “Exp Dec 2022”. No other lots of this product are impacted. This lot is being recalled due to the presence of Ralstonia pickettii bacteria (R. pickettii), which was discovered by the manufacturer through routine testing.

R. pickettii is present in the environment (soil, water) and for healthy individuals with intact skin, is unlikely to cause any localized or systemic infections. However, for individuals who are immunocompromised or whose skin is not intact (sunburn, psoriasis, abrasions), there is a reasonable possibility that systemic infections may occur if the product is contaminated with R. pickettii. This is due to the presence of the corticosteroid component which enhances absorption of the ointment. If this bacterium is circulating in the human blood stream it can cause life-threatening, invasive infections such sepsis, pneumonia, meningitis, inflammation of the bone or bone marrow, and infection in the joint fluid and joint tissues. To date, Taro has not received any adverse event reports related to this lot.

Lot Number	Amount	Expiration Date
AC13786	96 units	December 2022

Clobetasol Propionate Ointment USP, 0.05% is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses and is packaged in 60 g aluminum tubes with polypropylene puncture-tip caps. Each 60 g tube is labeled to indicate the name of the product, Clobetasol Propionate Ointment USP, 0.05% and the NDC # 51672-1259-03 (image of container label is linked on the following page). The lot number and expiration date are displayed on the bottom of each tube and the end flap of the product carton.

Ninety-six (96) units of lot AC13786 were distributed to two wholesale distributors in the United States (US) market between November 16 and December 6, 2021. These two wholesale distributors may have further distributed this lot to their retail customers for prescription dispensing to patients who were prescribed Clobetasol Propionate Ointment USP, 0.05%, 60 g.

Taro has notified the affected distributors by phone, e-mail, and letters via US Mail and is arranging for return of any containers of Clobetasol Propionate Ointment USP, 0.05%, 60 g, Lot AC13786 (expiration date of December 2022). Retail customers that have any quantities of Lot AC13786 which is being recalled, should stop distribution and return any unsold units to their wholesaler.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the US Food and Drug Administration.

Company Contact Information

Consumers:

Taro Pharmaceuticals U.S.A., Medical Information
1-866-923-4914
TaroPVUS@taro.com

Product Photos

Click here for product photos.

About this recall:

Padagis has issued a voluntary nationwide recall to the consumer/user level of 3 lots of Nitroglycerin Lingual Spray (NDC 45802-0210-02). Out of an abundance of caution, this product is being recalled due to a complaint that the drug may not dispense from the spray bottle. This recall applies only to the 12 gram spray bottle and not the 4.9 gram spray bottle of this medication. The 3 specific recalled lots are listed in the table provided at the FDA press release on the following page.

What this means to you:

Nitroglycerin Lingual Spray is indicated for acute relief of an attack or prevention of chest pain due to coronary artery disease (CAD) in adult patients. If the product does not deliver the appropriate amount of nitroglycerin, the patient will likely continue to experience chest pain. The label advises that if relief is not obtained after 3 doses over 15 minutes, the patient should promptly seek medical attention. To date, Padagis has not received any reports of adverse events related to this recall.

Padagis is notifying its distributors/customers by express package delivery service as well as electronic mail and is arranging for return of all recalled products. All customers, healthcare providers, and consumers are instructed to examine their inventory for the recalled lots of Nitroglycerin Lingual Spray immediately and to quarantine, discontinue the distribution and use of, and return all recalled lots of the product. Patients who have this product should contact their healthcare provider for an alternate replacement before returning the recalled product.

Patients with questions regarding this recall can contact 888-266-7912 Monday to Friday from 8 am to 5 pm EST. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product or any medical concerns.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:
Padagis has issued a voluntary nationwide recall to the consumer/user level of 3 lots of Nitroglycerin Lingual Spray. Out of an abundance of caution, this product is being recalled due to a complaint that the drug may not dispense from the spray bottle. There is a remote risk that the product may not properly dispense medication to patients in the event of a malfunction of their dispensing unit. This recall applies only to the 12 gram spray bottle and not the 4.9 gram spray bottle of this medication. Lots recalled are listed in the table below.

Nitroglycerin Lingual Spray

NDC	Strength	Net Contents	Lot Number	Expiration
45802-0210-02	400 mcg per spray	12 grams	150892	Oct 2022
45802-0210-02	400 mcg per spray	12 grams	153199	Feb 2023
45802-0210-02	400 mcg per spray	12 grams	156041	Apr 2023

Risk Statement: If the product does not deliver the appropriate amount of nitroglycerin, the patient will likely continue to experience chest pain. The label advises that if relief is not obtained after 3 doses over 15 minutes, the patient should promptly seek medical attention. To date, Padagis has not received any reports of adverse events related to this recall.

Nitroglycerin Lingual Spray is indicated for acute relief of an attack or prophylaxis of chest pain due to coronary artery disease (CAD) in adult patients. All packaging and branding on impacted units is that of Perrigo Company PLC. The product is packaged in a 12 gram bottle contained within a carton. The medication was distributed nationwide in the United States (US) to wholesalers and retailers.

Padagis is notifying its distributors and customers by express package delivery service as well as electronic mail and is arranging for return of all recalled products. All customers, healthcare providers (HCPs), and consumers are instructed to examine their inventory for recalled Nitroglycerin Lingual Spray immediately and to quarantine, discontinue the distribution and use of, and return all recalled lots of the product. Customers and HCPs are being provided recall information by Sedgwick Claims Management Services. All customers who have distributed this product to consumers have been requested to identify their customers and notify them immediately of the or 888-266-7912.

HCPs, distributors, and retailers that have product which is being recalled should stop distribution. Patients who have this product should contact their HCP for an alternate replacement before returning the recalled product. The necessary form to document product information, as well as other information, is available by contacting Sedgwick atpadagis5665@sedgwick.comor 888-266-7912.

Patients with questions regarding this recall can contact 888-266-7912 Monday to Friday from 8am to 5pm EST. Patients should contact their physician or HCP if they have experienced any problems that may be related to using this product or any medical concerns.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’sMedWatch Adverse EventReporting program either online, by regular mail or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the US Food and Drug Administration.

Company Contact Information

Consumers:

Sedgwick888-266-7912
padagis5665@sedgwick.com

Product Photos

Click here for product photos.

About this recall:
Sandoz is initiating a recall of 1 lot (SAB06761A, Exp. 04/2023) of Enoxaparin Sodium Injection, USP 40 mg/0.4 mL Single-Dose Syringes to the consumer level. A portion of lot SAB06761A experienced a temperature excursion during shipment.

This lot was shipped to customers in the months of September and October 2021.

These patients could be at risk for blood clots blocking blood vessels, an artery, or traveling to other tissues or organs causing pain, swelling, stroke, clots in the lung, or death as a result of the underlying condition. To date, Sandoz has not received any reports of adverse events or injuries related to this recall.

The product is used for prevention of deep vein thrombosis (DVT), a condition that occurs when a blood clot forms in a deep vein, usually in the legs, that can occur after surgeries or in patients with restricted mobility during illness. Enoxaparin is also used for prevention of complications associated with heart attacks. The product is packaged in cartons containing ten 0.4 mL syringes, NDC 00781-3246-64. Enoxaparin Sodium Injection was distributed nationwide in the United States (US) to wholesalers and retailers.

Product Name	NDC	Lot Number	Expiration Date	Date of Manufacture
Enoxaparin Sodium Injection,USP 40 mg/0.4 mL	00781-3246-64	SAB06761A	04/2023	05/26/2021

Please note: this recall is specific to only one batch (SAB06761A) of Enoxaparin Sodium Injection, USP 40 mg/ 0.4 mL and does not apply to any other strengths of Sandoz Enoxaparin Sodium Injection, USP or to other lots of the 40 mg/0.4 mL SKU. Any product returned that is not associated with this recall will be destroyed and no credit issued.

Sandoz has already notified its wholesalers and retailers by mail and is arranging for return of all recalled product.

Consumers who have Enoxaparin Sodium Injection, USP 40 mg/0.4 mL (NDC 0781-3246-64 and lot number SAB06761A) which is being recalled, should stop taking the recalled product and immediately consult with their physician to attain another prescription. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Retailers and consumers should contact Sedgwick directly by phone at 844-265-7389 to return the recalled product. Representatives are available Monday to Friday, 8 am to 5 pm ET.

In case of any adverse reactions, please call Sandoz at (800) 525-8747 or email qa.drugsafety@sandoz.com. Customer service agents are available Monday to Friday from 8:30 am to 5 pm ET. Adverse events can also be reported to FDA online.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch. Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the US Food and Drug Administration.

Link to FDA recall notification

Company Contact Information

Consumers:

Sedgwick
844-265-7389 sandoz4623@sedgwick.com

Product Photos
Click here for product photos.

About this recall:

Efficient Laboratories is expanding its voluntary nationwide recall to consumers to include an additional 12 lots of Rompe Pecho CF, Rompe Pecho EX, Rompe Pecho MAX, and Rompe Pecho DM due to microbial contamination concerns. These lots were distributed in 2019. To date, Efficient Laboratories has not received any reports of adverse events.

What this means to you:

In rare circumstances, consumption of these specific lots could result in illness. These products are used to treat symptoms of the flu and the common cold, and each are packaged in a box containing a bottle of the liquid product.

The lot numbers and expiration dates can be found on the bottom of the cartons. These Rompe Pecho products were distributed nationwide to wholesalers and retailers. Consumers that have Rompe Pecho EX, Rompe Pecho CF, Rompe Pecho DM, or Rompe Pecho MAX from the lots that are being recalled should stop using these products and discard them. The impacted 12 lots of Rompe Pecho product are listed in the chart on the following page.

Consumers with questions regarding this recall can contact Efficient Laboratories by phone at (305) 805-3456, Monday through Friday from 9 am to 4:30 pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Product Name	Lot	Expiration Date
Rompe Pecho CF	19F88	June 2022
Rompe Pecho CF	19G164	July 2022
Rompe Pecho DM	19F168	June 2022
Rompe Pecho DM	19G145	July 2022
Rompe Pecho DM	19G361	July 2022
Rompe Pecho DM	19G449	July 2022
Rompe Pecho DM	19G491	July 2022
Rompe Pecho EX	19H20	Aug 2022
Rompe Pecho EX	19J98	Sep 2022
Rompe Pecho EX	19A418	Jan 2022
Rompe Pecho EX	19E411	May 2022
Rompe Pecho MAX	19G219	July 2022

About this recall:

What this means to you:

About this recall:

What this means to you:

Product Name	Lot	Expiration Date
Rompe Pecho CF	19F88	June 2022
Rompe Pecho CF	19G164	July 2022
Rompe Pecho DM	19F168	June 2022
Rompe Pecho DM	19G145	July 2022
Rompe Pecho DM	19G361	July 2022
Rompe Pecho DM	19G449	July 2022
Rompe Pecho DM	19G491	July 2022
Rompe Pecho EX	19H20	Aug 2022
Rompe Pecho EX	19J98	Sep 2022
Rompe Pecho EX	19A418	Jan 2022
Rompe Pecho EX	19E411	May 2022
Rompe Pecho MAX	19G219	July 2022

The lot numbers and expiration dates can be found on the bottom of the cartons. These Rompe Pecho products were distributed nationwide to wholesalers and retailers.

Consumers that have Rompe Pecho EX, Rompe Pecho CF, Rompe Pecho DM, or Rompe Pecho MAX from these lots that are being recalled should stop using these products and discard them. Efficient Laboratories has notified its distributors of these lots. All distributors have confirmed there is no product in their inventory. In addition, a review of certain stores confirmed no inventory at the retail level as well.

Adverse events or product complaints experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration (FDA).

Initial press release

Link to FDA recall notification

Company Contact Information

Consumers:

Efficient Laboratories
305-805-3456

Product Photos

Click here for product photos

About this recall:

Sandoz is initiating a recall of 1 lot of Enoxaparin Sodium Injection, USP 40 mg/0.4 mL Single-Dose Syringes because a portion of the lot experienced a temperature excursion during shipment.

What this means to you:

The exposure to higher temperatures may have significantly impacted the recalled product’s (lot SAB06761A) effectiveness and thus there may be reasonable probability of risk for patients with health conditions that the product is intended to treat. These patients could be at risk for blood clots blocking blood vessels, an artery, or traveling to other tissues or organs causing pain, swelling, stroke, clots in the lung, or death as a result of the underlying condition. To date, Sandoz has not received any reports of adverse events or injuries related to this recall.

Please note: this recall is specific to only one batch (SAB06761A) of Enoxaparin Sodium Injection, USP 40 mg/ 0.4 mL and does not apply to any other strengths of Sandoz Enoxaparin Sodium Injection, USP or to other lots of the 40 mg/0.4 mL. Any product returned that is not associated with this recall will be destroyed and no credit issued.

Consumers who have Enoxaparin Sodium Injection, USP 40 mg/0.4 mL (NDC 00781-3246-64 and lot number SAB06761A) which is being recalled, should stop taking the recalled product and immediately consult with their physician to attain another prescription. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Consumers should contact Sedgwick directly by phone at 844-265-7389 to return the recalled product. Representatives are available Monday to Friday from 8 am to 5 pm ET.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:

Lupin is voluntarily recalling irbesartan tablets and irbesartan/HCTZ tablets to the consumer level. As part of Lupin’s ongoing assessment, analysis revealed that certain tested active pharmaceutical ingredient (API) batches, but not finished product batches, were above the limit for the impurity, N-nitrosoirbesartan. Although no reports of illness that appear to relate to this issue have been received, out of an abundance of caution, Lupin is recalling all batches of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg as well as Irbesartan/HCTZ Tablets, USP 150 mg/12.5 mg and 300 mg/12.5 mg in the United States (US).

What this means to you:

N-nitrosoirbesartan impurity is a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

Irbesartan/HCTZ tablets are a combination of irbesartan (an ARB) and HCTZ (a thiazide diuretic), indicated for hypertension in patients not adequately controlled with monotherapy or as an initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.

Patients taking irbesartan tablets, USP 75 mg, 150 mg, and 300 mg or irbesartan/HCTZ tablets, USP 150 mg/12.5 mg and 300 mg/12.5 mg that have been recalled are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. The link below provides a complete listing of recalled products.

Patients with questions regarding this recall should contact Inmar Rx Solutions at (855) 769-3988 / (855) 769-3989 Monday to Friday 9 am to 5 pm EST. For reimbursement, please have the recalled lots returned to Inmar Rx Solutions; the lot number can be found on the side of the bottle label.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:
Lupin is voluntarily recalling the below mentioned batches of irbesartan tablets and irbesartan/hydrochlorothiazide (HCTZ) tablets to the consumer level. As part of Lupin’s ongoing assessment, analysis revealed that certain tested active pharmaceutical ingredient (API) batches, but not finished product batches, were above the specification limit for the impurity, N-nitrosoirbesartan. Although no reports of illness that appear to relate to this issue have been received, out of an abundance of caution, Lupin is recalling all batches of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg as well as Irbesartan/HCTZ Tablets, USP 150 mg/12.5 mg and 300 mg/12.5 mg in the United States (US).

Lupin discontinued the marketing of irbesartan and irbesartan/HCTZ tablets on January 7, 2021. The products were distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies, and supermarkets.

Risk Statement: N-nitrosoirbesartan impurity is a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

From October 8, 2018 (the earliest date of shipment from the manufacturing site of any of the impacted batches), to September 30, 2021, Lupin received 4 reports of illness from irbesartan and 0 reports from irbesartan/HCTZ.

Irbesartan is an angiotensin II receptor blocker (ARB) indicated for treatment of hypertension (to lower blood pressure) and for the treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg are packaged in 30- and 90-count bottles and were distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies, and supermarkets.

The recalled lots are included in the table on the following page and have distribution dates from 10/20/2018 to 12/03/2020.

Product	Lot Number	NDC (tablet count)
Irbesartan Tablets, USP 75 mg	H000843, H805727, H901579	68180-0410-06 (30's)
Irbesartan Tablets, USP 75 mg	H000844, H000964, H804311, H805267, H805268, H805269, H805725, H805726, H901497, H901577, H901578, H902258	68180-0410-09 (90's)
Irbesartan Tablets, USP 150 mg	H804403, H805251, H805640, H901580	68180-0411-06 (30's)
Irbesartan Tablets, USP 150 mg	H804492, H805252, H805253, H805641, H805642, H805643, H901581, H902139, H902140	68180-0411-09 (90's)
Irbesartan Tablets, USP 300 mg	H804310, H900050, H902262	68180-0412-06 (30's)
Irbesartan Tablets, USP 300 mg	H000845, H000846, H000965, H805345, H805346, H805347, H805724, H900061, H900062, H900445, H901489, H901490, H901491, H902261	68180-0412-09 (90's)

Lupin is notifying its wholesalers, distributors, drug chains, mail order pharmacies, and supermarkets by phone and through recall notification and is arranging for the return of all the recalled product lots.

Patients taking recalled irbesartan tablets, USP in the strengths of 75 mg, 150 mg, and 300 mg or irbesartan/HCTZ tablets USP, in the strengths of 150 mg/12.5 mg and 300 mg/12.5 mg are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.

Wholesalers, distributors, and retailers that have irbesartan and irbesartan/HCTZ tablets that are being recalled should discontinue distribution of the recalled product lots immediately and return it to Inmar Rx Solutions at 635 Vine Street, Winston Salem, NC 27101.

Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions at (855) 769-3988 / (855) 769-3989 Monday to Friday 9 am to 5 pm EST. For reimbursement, please have the recalled lots returned to Inmar Rx Solutions; the lot number can be found on the side of the bottle label.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the US Food and Drug Administration.

Link to FDA recall notification

Company Contact Information

Consumers:
Inmar Rx Solutions, Inc.
(855) 769-3988 / (855) 769-3989

Media:
Shweta Munjal
shwetamunjal@lupin.com

Product Photos

Click here for product photos.

About this recall:

Bayer is voluntarily recalling all unexpired Lotrimin® AF and Tinactin® spray products with lot numbers beginning with TN, CV, or NAA, distributed between September 2018 to September 2021, to the consumer level due to the presence of benzene in some samples of the products.

Drugs recalled (manufacturer):

Lotrimin AF and Tinactin Spray Products (Bayer)

NDCs impacted:

11523-1272-02, 11523-0010-02, 11523-4162-01, 11523-4140-02, 11523-0544-02, 11523-0777-02, 11523-0165-03, 11523-0072-05

What this means to you:

Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin. Depending on duration and level of exposure, it can result in cancers including leukemia as well as blood cancer of the bone marrow and blood disorders which can be life-threatening. Benzene is found in the environment from natural sources and human activity. Humans around the world are exposed to it from multiple sources and pathways, including inhalation, through the skin, and orally. To date, Bayer has no known reports of adverse events related to this recall. Bayer’s decision to voluntarily recall these products is a precautionary measure, and the levels detected are not expected to cause adverse health consequences in consumers.

The affected Lotrimin® and Tinactin® spray products are over-the-counter antifungal products, sold individually or in combo packs. Product images and information on which lot numbers fall under this recall are available at https://livewell.bayer.com/document/2011. There are no issues of concern with Lotrimin/Tinactin creams, including Lotrimin Ultra, or any other Bayer products. The recalled products are all packaged in aerosol spray cans. The products were distributed in the United States (US), Puerto Rico, Canada, and Mexico through a variety of retail channels.

Consumers may request a refund by visiting www.lotrimin.com or www.tinactin.com, and may contact Bayer with questions by calling 1-866-360-3266, Monday to Friday between the hours of 8 am and 8 pm Eastern Time. A photo of the product will be required to receive a refund. After taking your photo and completing the refund process, please discard the product appropriately. According to the FDA, consumers who have the products that are being recalled should stop using the product. Consumers should contact their healthcare provider if they have any questions, concerns or have experienced any problems related to using these aerosol antifungal products.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

Reason for Recall:

Drug recalled (manufacturer):

Lotrimin AF and Tinactin Spray Products (Bayer)

NDCs impacted:

11523-1272-02, 11523-0010-02, 11523-4162-01, 11523-4140-02, 11523-0544-02, 11523-0777-02, 11523-0165-03, 11523-0072-05

Actions for Member:

All members who have filled prescriptions through our systems for Lotrimin AF and Tinactin Spray Products in the past 3 months will also receive a written notice of this recall. The letter directs the member to discuss any concerns with their prescriber. You may be contacted by these members to discuss any impact. The summary below is being communicated to patients.

Consumers may request a refund by visiting www.lotrimin.com or www.tinactin.com, and may contact Bayer with questions by calling 1-866-360-3266, Monday to Friday between the hours of 8 am and 8 pm Eastern Time. A photo of the product will be required to receive a refund. After taking your photo and completing the refund process, please discard the product appropriately. According to the FDA, consumers who have the products that are being recalled should stop using the product. Consumers should contact their healthcare provider if they have any questions, concerns or have experienced any problems related to using these aerosol antifungal products.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:

Eli Lilly and Company (Lilly) is voluntarily recalling lot D239382D, expiration April 2022, of Glucagon Emergency Kit for Low Blood Sugar (glucagon for injection, 1 mg per vial; diluent for glucagon, 1 mL syringe), to the consumer (user) level. Lilly is recalling lot D239382D to the patient level because of a product complaint that the vial of glucagon was in liquid form instead of the powder form. The use of the liquid form of this product may fail to treat severe low blood sugar due to loss of potency.

Drug recalled (manufacturer): Glucagon Emergency Kit (Lilly)

NDC impacted (lot, expiration): 00002-8031-01
(Lot): D239382D
(Expiration): April 2022

What this means to you:

Severe hypoglycemia in patients with diabetes, if not reversed, can potentially cause adverse health consequences ranging from transient, minor complaints to neurological damage, seizures, and even death, if not promptly treated. Associated with the one product complaint, it was reported to Lilly that the involved patient experienced lack of drug effect and also reported subsequent seizures.

Glucagon Emergency Kit is used as an anti-hypoglycemic agent and a gastrointestinal motility inhibitor indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus. The product is packaged in a kit containing 1 mg of freeze-dried (lyophilized) product in a 3 mL vial and a pre-filled diluent syringe. The recalled Glucagon Emergency Kit, NDC 00002-8031-01, lot is D239382D, and the expiration date is April 2022 (label expiry date: 04 2022). The lot number can be found on the label of the kit as well as the vial.

Consumers in possession of Glucagon Emergency Kit lot D239382D should contact The Lilly Answers Center at 1-800-LILLYRX (1-800-545-5979) for return and replacement instructions for the product (Monday through Friday, 9 AM to 7 PM EST) and should contact their healthcare provider (HCP) for guidance. Consumers should contact their physician or HCP if they have experienced any problems that may be related to taking or using this product.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:
Eli Lilly and Company (Lilly) is voluntarily recalling lot D239382D, expiration April 2022, of Glucagon Emergency Kit for Low Blood Sugar (glucagon for injection, 1 mg per vial; diluent for glucagon, 1 mL syringe), to the consumer (user) level. Lilly is recalling lot D239382D to the patient level because of a product complaint that the vial of glucagon was in liquid form instead of the powder form. The firm’s investigation indicates that the liquid in this glucagon vial could be related to the manufacturing process. The use of the liquid form of this product may fail to treat severe low blood sugar due to loss of potency.

Risk Statement: Severe hypoglycemia in patients with diabetes, if not reversed, can potentially cause adverse health consequences ranging from transient, minor complaints to neurological damage, seizures, and even death, if not promptly treated. Associated with the one product complaint, it was reported to Lilly that the involved patient experienced lack of drug effect and also reported subsequent seizures.

Lilly is notifying its distributors and customers by written communication and is arranging for return and replacement of all recalled products. Wholesalers and distributors with an existing inventory of Glucagon Emergency Kit lot D239382D should cease distribution and quarantine the product immediately.

Instructions for Wholesalers and Pharmacists

If you have distributed the recalled product, please notify any accounts or additional locations which may have received product from the recalled lot from you. Please conduct a sub-recall to those accounts and communicate this recall information immediately. Please request they immediately cease distribution of the product and promptly contact Sedgwick at 877-907-7032 (Interactive Voice Recording), 877-884-9410 (Fax), or elililly7484@sedgwick.com (Monday through Friday 8 am to 5 pm ET) to obtain a Business Reply Card (BRC) to initiate the return process.

Instructions for Consumers

Consumers in possession of Glucagon Emergency Kit lot D239382D should contact The Lilly Answers Center at 1-800-LILLYRX (1-800-545-5979) for return and replacement instructions for the product (Monday through Friday, 9 am to 7 pm EST) and should contact their healthcare provider (HCP) for guidance. Consumers should contact their physician or HCP if they have experienced any problems that may be related to taking or using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States Food and Drug Administration (FDA).

Link to FDA recall notification

Company Contact Information

Consumers:

The Lilly Answers Center
1-800-545-5979

Media:
Gregory A. Kueterman
317-432-5195
kueterman_gregory_andrew@lilly.com

Product Photos
Click here for product photos.

About this recall:

Pfizer is voluntarily recalling all lots of Chantix 0.5 mg and 1 mg tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA’s interim acceptable intake limit. This is an expansion of previously announced recalls.

Drug recalled (manufacturer): Chantix 0.5 mg and 1 mg tablets (Pfizer)
NDC(s) impacted: 0069-0468-56, 0069-0469-56, 0069-0469-03, 0069-0471-03

What this means to you:
Long-term ingestion of N-nitroso-varenicline may be associated with a potential increased cancer risk, but there is no immediate risk to patients taking this medication. The health benefits of stopping smoking outweigh the theoretical cancer risk from the nitrosamine impurity in varenicline. Nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

Chantix is a treatment to help patients quit smoking and is intended for short-term use. People who smoke cigarettes are 15 to 30 times more likely to get lung cancer than people who do not smoke. Smoking is also associated with many other cancers, as well as with heart and lung disease. Chantix has a safety profile that has been established over 15 years of marketing authorization. Pfizer believes the benefit/risk profile of Chantix remains positive. Patients currently taking Chantix should consult with their healthcare provider (HCP) about alternative treatment options. To date, Pfizer has not received reports of adverse events that have been related to this recall.

As communicated by the FDA, there is no immediate risk to patients taking Chantix. Patients who are taking this product should consult with their HCP to determine if alternative treatments are available. Patients with recalled Chantix tablets should contact Stericycle at 888-276-6166 (Monday to Friday, 8 am to 5 pm ET) for instructions on how to return their product and obtain reimbursement for their cost.

The NDCs, lot numbers, expiration dates, presentations, and photos for recalled Chantix tablets are available at the link provided on the following page.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.

Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:
Jacobus is voluntarily recalling 3 lots of Ruzurgi® (amifampridine) 10 mg tablets to the consumer level. The products have been found to be contaminated with yeast, mold, and aerobic bacteria based on laboratory test results.

What this means to you:
hreatening infections. The use of the contaminated product in patients with underlying immunosuppressive conditions such as Lambert-Eaton myasthenic syndrome (LEMS) increases the potential for serious infections. Ruzurgi is used as a treatment for LEMS in patients ages 6 years old to less than 17 years old.

It is packaged in 100-count bottles (NDC: 49938-0110-01). The 3 recalled Ruzurgi lots include the following control numbers, expiration dates, and distribution dates:

Control Number	Expiration Date	Distribution Dates
18038	03/2023	05/25/2021 – 08/26/2021 (Canada only)
18039	03/2023	06/01/2021 – 08/10/2021
18079	05/2023	08/10/2021 – 08/30/2021

Jacobus is arranging for return of all recalled products. Consumers that have Ruzurgi which is being recalled should stop using and return the product.

If shipping via US Postal Service ship to:
Jacobus Pharmaceutical Company, Inc.
P.O. Box 5290
Princeton, NJ 08540

If shipping via courier service (e.g., UPS, FedEx) ship to:
Jacobus Pharmaceutical Company, Inc.
IRL Building
31 Schalks Crossing Road
Plainsboro, NJ 08356

Consumers with questions regarding this recall can contact Jacobus by phone at (609) 799-8221 ext. 2120, Monday through Friday from 9 AM to 5 PM Eastern Standard Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration (FDA) and other health authorities.

Link to FDA recall notification

Company Contact Information

Consumers:

Jacobus Pharmaceutical Company Inc.

609-799-8221 ext. 2120

Product Photos

Click here for product photos

It is packaged in 100-count bottles (NDC: 49938-0110-01). The 3 recalled Ruzurgi lots include the following control numbers, expiration dates, and distribution dates:

Control Number	Expiration Date	Distribution Dates
18038	03/2023	05/25/2021 – 08/26/2021 (Canada only)
18039	03/2023	06/01/2021 – 08/10/2021
18079	05/2023	08/10/2021 – 08/30/2021

Jacobus is arranging for return of all recalled products. Consumers that have Ruzurgi which is being recalled should stop using and return the product.

If shipping via US Postal Service ship to:
Jacobus Pharmaceutical Company, Inc.
P.O. Box 5290
Princeton, NJ 08540

If shipping via courier service (e.g., UPS, FedEx) ship to:
Jacobus Pharmaceutical Company, Inc.
IRL Building
31 Schalks Crossing Road
Plainsboro, NJ 08356

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:
Azurity is voluntarily recalling one (1) lot of Firvanq® (vancomycin hydrochloride [HCl] for oral solution), vancomycin 50 mg/mL kit to the consumer level, as some products in the recalled lot have been found to incorrectly contain a First® Omeprazole (FIRST®-PPI) diluent instead of the Firvanq diluent bottle.

Risk Statement: Vancomycin may not be completely solubilized in the FIRST-PPI diluent which could lead to doses above or below those recommended in the label. There is reasonable probability that the administration of inappropriate doses of oral vancomycin may lead to persistent diarrhea associated with dehydration and electrolyte abnormalities, recurrence of Clostridium difficile (C. difficile) infection, progression to severe colitis, colon perforation requiring colectomy, and potentially death. Especially, the elderly and immunocompromised patients are vulnerable to the complications of C. difficile infection. To date, Azurity has not received any reports of adverse events related to this recall.

Firvanq is indicated for use in adults and pediatric patients less than 18 years of age for the treatment of: Clostridium difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains). It is packaged as a kit consisting of a bottle with Vancomycin HCl, USP powder, a bottle of grape-flavored diluent, and the Prescribing Information. The product NDC is 65628-206-05 and the UPC code is 3 65628 206005 1. A total of 2,751 kits of the recalled Firvanq, lot number 21035, with an expiration date of 07-31-2022 were distributed. The product can be identified by its brand name Firvanq, NDC, and lot number. Product was distributed nationwide through wholesale distributors.

Azurity is notifying its distributors and customers by direct notifications to distributors and via this press release. Azurity is arranging for return and replacement of only recalled products. Consumers, distributors, and retailers that are in possession of Firvanq from the impacted lot should immediately stop using it and return it to the place of purchase. Distributors are asked to place any impacted product under quarantine and return it promptly to Azurity.

Consumers with questions regarding this recall may contact Koral Couch, Senior Manager, Customer Service by phone: 781-935-8141 x 119; fax: 781 935-8395, or email: kcouch@azurity.com. Azurity business hours are Monday through Friday from 8:30 am to 5 pm Eastern Time. Consumers should contact their physician or healthcare provider (HCP) if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration (FDA).

Link to FDA recall notification

Company Contact Information
Consumer:

Koral Couch
781-935-8141 x 119
kcouch@azurity.com

Product Photos

Click here for product photos.

About this recall:
Azurity is voluntarily recalling one (1) lot of Firvanq (vancomycin hydrochloride [HCl] for oral solution), vancomycin 50 mg/mL kit to the consumer level, as some products in the recalled lot have been found to incorrectly contain a First® Omeprazole (FIRST®-PPI) diluent instead of the Firvanq diluent bottle.

Drug recalled (manufacturer): Firvanq 50 mg/mL Kit (Azurity)

NDC impacted (lot number): 65628-0206-05 (lot number: 21035)

What this means to you:
Vancomycin may not be completely dissolved in the FIRST-PPI diluent which could result in doses above or below those recommended. Taking inappropriate doses of oral vancomycin may potentially lead to persistent diarrhea associated with dehydration and electrolyte abnormalities, recurrence of Clostridium difficile (C. difficile) infection, progression to severe colitis, colon perforation requiring surgery, and potentially death. Especially, the elderly and immunocompromised patients are vulnerable to the complications of C. difficile infection. To date, Azurity has not received any reports of adverse events related to this recall.

Firvanq is indicated for use in adults and pediatric patients less than 18 years of age for the treatment of: Clostridium difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains). It is packaged as a kit consisting of a bottle with vancomycin HCl powder and a bottle of grape-flavored diluent. The product NDC is 65628-0206-05. A total of 2,751 kits of the recalled Firvanq, lot number 21035, with an expiration date of 07-31-2022 were distributed. The product can be identified by its brand name Firvanq, NDC, and lot number.

Azurity is arranging for return and replacement of only recalled products. Consumers that are in possession of Firvanq from the recalled lot should immediately stop using it and return it to the place of purchase.

Consumers with questions regarding this recall may contact Koral Couch, Senior Manager, Customer Service by phone: 781-935-8141 x 119; fax: 781 935-8395, or email: kcouch@azurity.com. Azurity business hours are Monday through Friday from 8:30 am to 5 pm Eastern Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online at or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:
KVK Tech is voluntarily recalling 2 lots of Atovaquone Oral Suspension, USP 750 mg/5 mL to the consumer level. The recall is based on customer complaints of unusual grittiness in the product, which KVK has determined was most probably caused by prolonged exposure of these product lots to extremely cold weather during shipment.

What this means to you:
Atovaquone is a prescription drug used to treat Pneumocystis jiroveci [Pneumocystis carinii] pneumonia, a type of pneumonia most likely to affect people with human immunodeficiency virus (HIV) in teenagers and adults, and is also used to prevent patients with weakened immune systems from contracting this type of pneumonia.

Exposure of atovaquone oral suspension to extremely low temperatures may result in changes to the effectiveness, appearance, taste, and thickness of the liquid. As the product is required to be protected from freezing temperatures, severely immunocompromised patients who receive less effective drug may not have their serious or life-threatening infection treated adequately. To date, KVK Tech is not aware of any adverse events associated with this problem.

The product is packaged in 8 oz. bottles (210 mL bottle with child-resistant cap) packaged in a carton with NDC # 10702-223-21; the affected lots are labeled 16653A and 16654A with both lots having expiration dates of December 2022. The lot numbers and expiration dates can be found on the right bottom side of the labels on the bottles.

Patients or caregivers who have bottles of recalled atovaquone should stop using and should return the product to KVK Tech at 110 Terry Drive, Newtown, PA 18940. KVK Tech will arrange to reimburse customers for their costs in purchasing the product.

Consumers with questions regarding this recall can contact KVK Tech at recall@kvktech.com215-579-1842 Ext: 6002, Monday through Friday, 8 am to 4:30 pm EST or via email at . Consumers should contact their physician or healthcare professional if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration. For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online.

Exposure of atovaquone oral suspension to extremely low temperatures may result in changes to the effectiveness, appearance, taste, and thickness of the liquid. As the product is required to be protected from freezing temperatures, severely immunocompromised patients who receive less effective drug may experience inadequate treatment of serious and life-threatening infections. To date, KVK Tech is not aware of any adverse events associated with this problem.

Atovaquone is a prescription drug labeled to treat Pneumocystis jiroveci [Pneumocystis carinii] pneumonia, a type of pneumonia most likely to affect people with human immunodeficiency virus (HIV) in teenagers and adults, and is also used to prevent immunocompromised patients from contracting this type of pneumonia.

The product is packaged in 8 oz. bottles (210 mL bottle with child-resistant cap) packaged in a carton with NDC # 10702-223-21; the affected lots are labeled 16653A and 16654A, with both lots having expiration dates of December 2022. The lot numbers and expiration dates can be found on the right bottom side of the labels on the bottles.

The 2 lots of product were shipped to a single distributor, which has been notified as part of the recall. KVK Tech will be working with the distributor to ensure that the distributor’s customers return remaining inventory of the affected lots to KVK Tech for appropriate disposition. Patients or caregivers who have bottles of atovaquone affected by this recall should stop using and are requested to return the product to KVK Tech at 110 Terry Drive, Newtown, PA 18940, and KVK Tech will arrange to reimburse customers for their costs in purchasing the product.

Consumers with questions regarding this recall can contact KVK Tech at recall@kvktech.com215-579-1842 ext: 6002, Monday through Friday, 8 am to 4:30 pm EST or via email to . Consumers should contact their physician or healthcare professional if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 1-800-FDA-0178 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration.

Link to FDA recall notification.

Company Contact Information

Consumers:

KVK Tech

215-579-1842 Ext: 6002
recall@kvktech.com

Media:

Susan DiCroce
(215) 579-1842 Ext: 1260

Product Details

For a listing of product photos: click here.

About this recall:
Pfizer is voluntarily recalling 2 lots of Chantix 0.5 mg tablets, 2 lots of Chantix 1 mg tablets, and 8 lots of the Chantix kit of 0.5 mg/1 mg tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level.

Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.

Chantix is a treatment to help patients quit smoking and is intended for short term use. People who smoke cigarettes are 15 to 30 times more likely to get lung cancer than people who do not smoke. Smoking is also associated with many other cancers. Chantix has a safety profile that has been established over 15 years of marketing authorization and through a robust clinical program. Pfizer believes the benefit/risk profile of Chantix remains positive. Patients currently taking Chantix should consult with their healthcare provider (HCP) to confirm if they received a recalled lot, and if appropriate, about alternative treatment options. To date, Pfizer has not received any reports of adverse events that have been related to this recall.

As communicated by the FDA, there is no immediate risk to patients taking Chantix. Patients who are taking this product should consult with their HCP or pharmacy to determine if they have received a recalled lot. Patients with the recalled lots should contact Stericycle at 888-276-6166 (Monday to Friday 8 am to 5 pm ET) for instructions on how to return their product and obtain reimbursement for their cost.

The NDC, lot number, expiration date, and presentation for recalled Chantix tablets are available at the link provided on the following page.

Pfizer’s Voluntary Nationwide Recall For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:
Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. The health benefits of stopping smoking outweigh the potential cancer risk from the nitrosamine impurity in varenicline. Nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

Chantix is a treatment to help patients quit smoking and is intended for short-term use. People who smoke cigarettes are 15 to 30 times more likely to develop lung cancer than people who do not smoke.ii Smoking is also associated with many other cancers.iii Chantix has a safety profile that has been established over 15 years of marketing authorization and through a robust clinical program. Pfizer believes the benefit/risk profile of Chantix remains positive. Patients currently taking Chantix should consult with their healthcare provider (HCP) to confirm if they received an impacted lot, and if appropriate, about alternative treatment options. To date, Pfizer has not received any reports of adverse events that have been related to this recall.

As communicated by the FDA, there is no immediate risk to patients taking Chantix.iv Patients who are taking this product should consult with their HCP or pharmacy to determine if they have received a recalled lot. Patients with the recalled lots should contact Stericycle at 888-276-6166 (Monday to Friday 8 am to 5 pm ET) for instructions on how to return their product and obtain reimbursement for their cost.

Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified their direct consignees by letter to arrange for return of any recalled product. Wholesalers and distributors with an existing inventory of the lots, listed in the table below, should stop use and distribution and quarantine the product immediately. If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Please conduct a sub-recall to those accounts and communicate this recall information immediately.

Product Strength	NDC	Lot Number	Expiration Date	Presentation
0.5 mg	0069-0468-56	00019213	2022 Jan	56 tablets per bottle
0.5 mg	0069-0468-56	EC6994	2023 May	56 tablets per bottle
1 mg	0069-0469-56	EA6080	2023 Mar	56 tablets per bottle
1 mg	0069-0469-56	EC9843	2023 Mar	56 tablets per bottle
0.5/1 mg	0069-0471-03	00020231	2021 Sep	Carton containing 1 blister pack of eleven 0.5 mg tablets and 1 blister pack containing forty-two 1 mg tablets
0.5/1 mg	0069-0471-03	00020232	2021 Nov	Carton containing 1 blister pack of eleven 0.5 mg tablets and 1 blister pack containing forty-two 1 mg tablets
0.5/1 mg	0069-0471-03	000202357	2021 Dec	Carton containing 1 blister pack of eleven 0.5 mg tablets and 1 blister pack containing forty-two 1 mg tablets
0.5/1 mg	0069-0471-03	000202358	2022 Jan	Carton containing 1 blister pack of eleven 0.5 mg tablets and 1 blister pack containing forty-two 1 mg tablets
0.5/1 mg	0069-0471-03	00020716	2022 Jan	Carton containing 1 blister pack of eleven 0.5 mg tablets and 1 blister pack containing forty-two 1 mg tablets
0.5/1 mg	0069-0471-03	ET1600	2023 Jan	Carton containing 1 blister pack of eleven 0.5 mg tablets and 1 blister pack containing forty-two 1 mg tablets
0.5/1 mg	0069-0471-03	ET1607	2023 Jan	Carton containing 1 blister pack of eleven 0.5 mg tablets and 1 blister pack containing forty-two 1 mg tablets
0.5/1 mg	0069-0471-03	ET1609	2023 Jan	Carton containing 1 blister pack of eleven 0.5 mg tablets and 1 blister pack containing forty-two 1 mg tablets

Contact Name	Contact Information	Area of support
Pfizer Medical Information	800-438-1985, option 3. (Monday-Friday 9am-5pm EST)	For medical questions regarding the product
Pfizer Drug Safety	800-438-1985, option 1. (24/7)	To report adverse events and product complaints

The NDC, lot number, expiration date, and presentation for recalled Chantix tablets are shown in the table below. The product lots were distributed nationwide to wholesalers and distributors in the United States (US) and Puerto Rico from June 2019 to June 2021.

Consumers with questions regarding this recall can contact the recall processor Eversana Life Science Services by phone at 1-888-304-5022, option 1; Monday to Friday, 8:00 am – 7:00 pm CDT. Consumers should contact their physician or HCP if they have experienced any problems that may be related to taking or using this drug product.

Customers with medical-related questions, who wish to report an adverse event, or quality issues about the recalled products should contact Viona by phone at 888-304-5011, Monday to Friday, 8:30 am – 5:30 pm EST.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular mail or fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the US FDA.

Link to FDA recall notification

Company Contact Information
Consumers:
Eversana Life Science Services
1-888-304-5022, option 1

Product Photos
Click here for product photos.

About this recall:
Viona is voluntarily recalling 2 lots of metformin hydrochloride (HCl) extended-release (ER) tablets, USP 750 mg to the retail level. The 2 lots of metformin HCl ER tablets, 750 mg have been found to contain levels of N-Nitrosodimethylamine (NDMA) above acceptable daily limits. This product was manufactured by Cadila Healthcare in November 2019 for United States (US) distribution by Viona.

What this means to you:
NDMA is classified as a substance that could cause cancer based on results from laboratory tests. NDMA is an environmental contaminant, found in water and foods (including meats, dairy products, and vegetables). Patients who have received recalled lots of metformin HCl ER tablets 750 mg are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment. According to the FDA, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their healthcare professionals (HCPs). To date, neither Viona, nor Cadila Healthcare have received any reports of adverse events related to this recall.

Metformin is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in plastic bottles of 100 tablets, under NDC 72578-036-01. The recalled lots (batches) of metformin HCl ER tablets 750 mg are listed at the link in the box on the following page. The product can be identified as white to off-white, capsule shaped, uncoated tablets, debossed with “Z”, “C” on one side and “20” on the other side.

For more information regarding this FDA Recall Notification, please refer to the FDA website here.

FDA contact information for reporting adverse events/quality complaints can be reached online here or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:
Viona is voluntarily recalling 2 lots of metformin hydrochloride (HCl) extended-release (ER) tablets, USP 750 mg to the retail level. The 2 lots of metformin HCl ER tablets, USP 750 mg have been found to contain levels of N-Nitrosodimethylamine (NDMA) above acceptable daily limits. This product was manufactured by Cadila Healthcare in November 2019 for United States (US) distribution by Viona.

Risk Statement:
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods (including meats, dairy products, and vegetables). Patients who have received impacted lots of metformin HCl ER tablets, USP 750 mg are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment. According to the Food and Drug Administration (FDA), it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their healthcare professionals (HCPs). Please visit the agency’s website for more information at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin. To date, neither Viona, nor Cadila Healthcare have received any reports of adverse events related to this recall.

The product is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in high-density polyethylene (HDPE) plastic bottles of 100 tablets, under NDC 72578-036-01. The impacted lots of metformin HCl ER tablets, USP 750 mg are listed in the table on the following page. The product can be identified as white to off-white, capsule shaped, uncoated tablets, debossed with “Z”, “C” on one side and “20” on the other side. Product was distributed nationwide to distributors.

Product Description	NDC Number	Batch Number	Expiration Date
Metformin hydrochloride extended release tablets, USP 750 mg	72578-036-01	M915601, M915602	Oct 2022

Viona is notifying its customers by email and mail (FedEx Overnight) and is arranging for return of all recalled products to the recall processor at the following address:

Eversana Life Science Services
c/o Viona recall
ATTN: Returns Department
4580 S. Mendenhall Rd.
Memphis, TN 38141

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular mail or fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the US FDA.

Link to FDA recall notification

Company Contact Information
Consumers:
Eversana Life Science Services
1-888-304-5022, option 1

Product Photos
Click here for product photos.

About this recall:
Acella is voluntarily recalling certain lots listed at the link on the following page of 15 mg, 30 mg, 60 mg, 90 mg, and 120 mg NP Thyroid (levothyroxine [T4] and liothyronine [T3]) to the consumer level. The products are being recalled as routine testing has found these lots to be subpotent. The product contains less than 90% of the labeled amount of liothyronine (T3) and/or levothyroxine (T4).

What this means to you:
The FDA is advising patients currently taking NP Thyroid from the recalled lots not to discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.

Patients being treated for hypothyroidism (underactive thyroid) who receive subpotent NP Thyroid may experience signs and symptoms of hypothyroidism which may include fatigue, sensitivity to cold, constipation, dry skin, puffy face, hair loss, decreased heart rate, depression, thyroid gland swelling, and/or unexplained weight gain or difficulty losing weight. Pregnant women who receive subpotent product could experience miscarriage or negative fetal outcomes. In elderly patients and those with underlying cardiac disease, cardiac problems related to abnormal thyroid levels could occur.

Consumers with questions about the recall can email Acella at recall@acellapharma.com or contact Acella representatives at 1-888-424-4341, Monday through Friday from 8:00 am – 5:00 pm ET. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. To best identify recalled product, the NDCs, product description, lot numbers, expiration dates, and product photos are listed at the link on the following page.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration (FDA).

For more information regarding this FDA Recall Notification, please refer to the FDA website. FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:
Acella is voluntarily recalling certain lots listed at the link on the following page of 15 mg, 30 mg, 60 mg, 90 mg, and 120 mg NP Thyroid®, Thyroid Tablets, USP (levothyroxine [T4] and liothyronine [T3]) to the consumer level. The products are being recalled as routine testing has found these lots to be subpotent. The product contains less than 90% of the labeled amount of liothyronine (T3) and/or levothyroxine (T4).

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid) who receive subpotent NP Thyroid may experience signs and symptoms of hypothyroidism which may include fatigue, sensitivity to cold, constipation, dry skin, puffy face, hair loss, decreased heart rate, depression, thyroid gland swelling, and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including the potential for early miscarriage, fetal thyroid problems, and/or impairments to fetal neural and skeletal development. In elderly patients and those with underlying cardiac disease, cardiac manifestations of thyroid problems may occur. To date, Acella has received 43 reports of serious adverse events that could possibly be related to this recall.

NP Thyroid is composed of levothyroxine and liothyronine and is used to treat hypothyroidism. The products subject to recall are packed in 100-count and 7-count bottles. Product images are provided at the link on the following page. To best identify recalled product, the NDCs, product description, lot numbers, and expiration dates are also listed at the link on the following page. These lots were distributed nationwide in the United States (US) to Acella’s direct accounts, including wholesalers, pharmacies, and healthcare offices.

Acella is proactively notifying its consignees to discontinue distribution of the recalled lots and is arranging for return of all recalled products. The FDA is advising patients currently taking NP Thyroid from the recalled lots not to discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the US Food and Drug Administration (FDA).

Link to FDA recall notification

Company Contact Information

Consumers:

Acella Pharmaceuticals

1-888-424-4341
recall@acellapharma.com

Product Details

For a listing of NDCs, lot numbers, expiration dates, and product photos: click here.

About this recall:

Bryant Ranch Prepack is voluntarily recalling in total 47 bottles of spironolactone tablets (4 different lots) to the consumer level. The products have been found to be mislabeled, displaying the incorrect strength. Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets and prepackaged bottles of spironolactone 25 mg may contain spironolactone 50 mg tablets.

What this means to you:

A patient who takes spironolactone 25 mg instead of the prescribed spironolactone 50 mg may have an increase in blood pressure or increase in swelling due to excess fluid (edema). It is possible that patients could have a decrease in potassium, if taking half of the expected dose, which could lead to low potassium levels or hypokalemia, a condition associated with heart rhythm disorders. Additionally, patients who take spironolactone 50 mg instead of the prescribed spironolactone 25 mg could have an increase in potassium, which could be life threatening. Patients with decreased kidney function or those taking certain other medications (for example: RAAS inhibitors, such as lisinopril, captopril, and others) would be at increased risk. Consumers with questions regarding this recall can contact Bryant Ranch Prepack at 877-885-0882 Monday through Friday 6:30 am to 6 pm PST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete
and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

For more information regarding this FDA Recall Notification, please refer to the FDA website. FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

About this recall:
Bryant Ranch Prepack is voluntarily recalling in total 47 bottles of spironolactone tablets (4 different lots) to the consumer level. The products have been found to be mislabeled, displaying the incorrect strength. Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets and prepackaged bottles of spironolactone 25 mg may contain spironolactone 50 mg tablets.

A patient who consumes spironolactone 25 mg instead of the prescribed spironolactone 50 mg may experience an elevation in blood pressure or increased swelling caused by excess fluid (edema) if taking the product chronically. It is possible that patients could experience a decrease in potassium if taking half of the expected dose which could lead to hypokalemia, a condition associated with cardiac arrhythmias. Furthermore, patients who consume spironolactone 50 mg instead of the prescribed spironolactone 25 mg could experience an increase in potassium which could be life-threatening. Patients with renal insufficiency or those taking concomitant reninangiotensin-aldosterone system (RAAS) inhibitors would be at increased risk. As of 3/9/2021, Bryant Ranch Prepack has not received any reports of adverse events related to this recall.

Spironolactone is indicated as a diuretic in the treatment of high blood pressure, heart failure, hypokalemia, and edema and is repackaged in 30, 60 and 90-count bottles. Lots included in recall:

Product Description	NDC	Lot Number	Expiration Date
Spironolactone 25 mg tablets	63629-1064-01	148969	7/31/2022
Spironolactone 25 mg tablets	63629-1064-02	148791	7/31/2022
Spironolactone 25 mg tablets	63629-1064-03	148991	7/31/2022
Spironolactone 50 mg tablets	63629-1067-01	148992	5/31/2022

The product can be identified by the following details on the label: medication name as listed above with strength in a bold black box and a red and blue “BRP Pharmaceuticals” logo. Photos of the labels are provided in the photo section linked below.

Bryant Ranch Prepack is notifying its distributors and customers by mail and is arranging for return of all recalled products. Distributors that have existing inventory of any of the lots listed in this recall should contact Bryant Ranch Prepack immediately.

Consumers with questions regarding this recall can contact Bryant Ranch Prepack at 877-885-0882 Monday through Friday 6:30 am to 6 pm PST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration (FDA).

Link to FDA recall notification

Company Contact Information Consumers:

Bryant Ranch Prepack
877-885-0882

Product Photos: Click here for product photos.

About this Recall:
Apotex is voluntarily recalling 2 batches of Enoxaparin Sodium Injection, USP to consumer level due to a packaging error resulting in some syringes barrels containing 150 mg/mL markings (corresponding to the 120 mg/0.8 mL strength) instead of 100 mg/mL markings (corresponding to the 100 mg/mL strength) on the syringe barrel and vice versa.

What this means to you:
Incorrect syringe barrel marking could result in inaccurate dose administration. In recalled batch CS008 (strength 100 mg/mL), patients could receive 3.75 mg of enoxaparin, instead of 3 mg of enoxaparin. In the other recalled batch (batch CT003, strength 120 mg/0.8 mL), patients could receive 2 mg of enoxaparin rather than 2.5 mg of enoxaparin. Accidentally taking too much drug may result in bleeding complications. Alternatively, if the dose administered is less than prescribed, blood clotting events could occur.

Enoxaparin sodium injection is used for the treatment of acute deep vein thrombosis (DVT), prevention of DVT which can lead to pulmonary embolism (PE), as well as for the prevention and treatment of certain cardiac events.

The recalled enoxaparin sodium injection can be identified by NDC numbers found on the carton and label of the product. The link on the following page provides these NDC numbers and additional details including the 2 recalled batch numbers.

Patients who have received either of the 2 impacted batches of enoxaparin sodium injection or have questions regarding this recall should contact their pharmacy. The FDA recommends patients not interrupt their therapy, immediately contact their healthcare provider for medical advice, and return the impacted product to Inmar Rx Solutions by contacting the number provided on the following page. 2— 0203-2021 Class 2 Enoxaparin Sodium Injection – Apotex Voluntary Nationwide Recall Consumers with the impacted units of Enoxaparin Sodium Injection, USP, please contact Inmar Rx Solutions (“Inmar”) at 1-855-667-8717, to receive a recall/return packet including the Recall Stock Response Form, or you may obtain this form from clsnetlink.com.

Consumers with questions regarding this recall can contact Apotex by phone at 1-800-706-5575 (8:30 am – 5 pm, EST Monday to Friday) or via email at UScustomerservice@Apotex.com.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

About this recall:
Apotex is voluntarily recalling 2 batches of Enoxaparin Sodium Injection, USP to the consumer level due to a packaging error resulting in some syringes barrels containing 150 mg/mL markings (corresponding to the 120 mg/ 0.8 mL strength) instead of 100 mg/mL markings (corresponding to the 100 mg/mL strength) on the syringe barrel and vice versa. The packaging error was discovered during a customer complaint investigation. To date, Apotex has not received any reports of adverse events related to use of these two batches. The affected product is manufactured by Gland Pharma.

Health Hazard Assessment:

Incorrect syringe barrel marking could lead to miscalculation and inaccurate dose administration. In one recalled batch (batch CS008, strength 100 mg/mL), if a consumer used a 150 mg/mL concentration packaged in a barrel corresponding to a 100 mg/mL concentration, the patient could receive 3.75 mg of enoxaparin, instead of 3 mg of enoxaparin. In another recalled batch (batch CT003, strength 120 mg/0.8 mL), if a consumer used a 100 mg/mL concentration packaged in a barrel corresponding to a 150 mg/mL concentration, the patient would receive 2 mg of enoxaparin rather than 2.5 mg of enoxaparin. Accidental overdosage could result in bleeding complications. Alternatively, if the dose administered is less than prescribed, the patient may experience blood clotting events.

Enoxaparin sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT) which may lead to pulmonary embolism (PE), treatment of acute DVT, prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (MI) when concurrently administered with aspirin, and treatment of acute STsegment elevation MI.

The 2 impacted batches of enoxaparin sodium injection, USP were distributed by Apotex nationwide in the United States (US) to wholesalers and warehousing chains. Apotex is currently notifying its affected direct account wholesalers and warehousing chains via mail (FedEx Standard Overnight) by mailing a recall notification letter and is arranging for return of all recalled product.

The impacted enoxaparin sodium injection can be identified by NDC numbers found on the carton and label of the product. The table on the following page also provides additional details including the 2 recalled batch numbers.

Product	Batch Number	Strength	Syringe Barrell Measurement Markings	Package Size	NDC Number on Carton	NDC Number on Label	UPC Code on Carton	UPC Code on Label
Enoxaparin Sodium Injection, USP	CS008	100 mg/mL	100 mg/mL	10 x 1 mL single dose syringes	60505-0795-4	60505-0795-1	360505079544	(01)10360505079510
Enoxaparin Sodium Injection, USP	CT003	120 mg/0.8mL	150 mg/mL	10 x 0.8 mL single dose syringes	60505-0796-4	60505-0796-0	360505079643	(01)10360505079602

Patients who have received either of the 2 recalled batches of enoxaparin sodium injection or have questions regarding this recall should contact their pharmacy. The FDA recommends individuals not interrupt their therapy, immediately contact their healthcare provider for medical advice, and return the impacted product to Inmar Rx Solutions by contacting the numbers provided in this press release.

Consumers with the affected units of enoxaparin sodium injection, please contact Inmar Rx Solutions (“Inmar”) at 1-855-667-8717, to receive a recall/return packet including the Recall Stock Response Form, or you may obtain this form from clsnetlink.com.

Consumers with questions regarding this recall can contact Apotex by phone at 1-800-706-5575 (8:30 am – 5 pm, EST Monday to Friday) or via email at UScustomerservice@Apotex.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Wholesalers, distributors, and retailers should return the recalled product to the place of purchase. Anyone with existing inventory should quarantine the recalled batches immediately. Customers who purchased the impacted product directly from Apotex can call Inmar Rx Solutions at 1-855-667-8717 (9:00 am – 5:00 pm, EST Monday to Friday), to arrange for their return.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the US Food and Drug Administration.

Link to FDA recall notification

Company Contact Information Consumers: Apotex Corp.

1-800-706-5575
UScustomerservice@Apotex.com

Media: Jordan Berman

1-416-749-9026
jberman@apotex.com

Product Photos: Click here for product photos.

About this Recall:
Nostrum is voluntarily recalling one (1) lot of metformin HCl ER tablets in the strength of 750 mg to the consumer level. This product is the generic equivalent to Glucophage® tablets.

The recalled metformin HCl ER 750 mg tablets have been found to contain levels of nitrosamine impurities above the acceptable daily intake limit of 96 ng/day. This is an expansion of the recall initially announced on November 2, 2020.

What this means to you:
N-Nitrosodimethylamine (NDMA) is classified as a substance that could cause cancer based on results from lab tests. NDMA is a known environmental contaminant and is found in water and foods (including meats, dairy products, vegetables).

The recalled tablets carry lot number MET200601 with expiration date 07/2022. The product can be identified as an off-white oblong tablet debossed with “NM7”.

Consumers should contact their physician or HCP if they have experienced any problems that may be related to taking this drug product. Consumers with medical questions regarding this recall can contact Nostrum Medical Affairs at phone number 816-308-4941 or email quality@nostrumpharma.com Monday through Friday from 8 am – 5 pm CST. Consumers should contact their physician or pharmacy for further medical advice.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

About this recall:
Nostrum Laboratories is voluntarily recalling one (1) lot of metformin hydrochloride (HCl) extended release (ER) tablets, USP 750 mg (generic equivalent to Glucophage® tablets) to the consumer level. The metformin HCl ER tablets, USP 750 mg have been found to contain levels of nitrosamine impurities above the acceptable daily intake (ADI) limit of 96 ng/day as published in the Food and Drug Administration (FDA) Guidance Document issued September 2020. This is an expansion of the recall initially announced on November 2, 2020.

N-Nitrosodimethylamine (NDMA) is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods (including meats, dairy products, vegetables). To date, Nostrum has not received any reports of adverse events related to this recall.

The product is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in high density polyethylene (HDPE) bottles of 100 tablets, under NDC 29033- 056-01. The affected lot of metformin HCl ER tablets, USP 750 mg is listed in the table. The product can be identified as an off-white oblong tablet debossed with “NM7”. Metformin HCl ER tablets, USP 750 mg was distributed nationwide to wholesalers.

Product Description: Metformin HCl Extended Release Tablets, USP 750 mg

NDC: 29033-056-01

Lot Number: MET200601

Expiry Date: 07/2022

Nostrum is notifying its distributors by letter and is arranging for return of all recalled products. Pharmacies that have metformin HCl ER tablets, USP 750 mg which are being recalled should return to place of purchase. Consumers should consult a healthcare professional (HCP) to obtain a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their HCP. Consumers should contact their physician or HCP if they have experienced any problems that may be related to taking this drug product.

Consumers with medical questions regarding this recall can contact Nostrum Medical Affairs by phone at 816-308- 4941 or email quality@nostrumpharma.com Monday through Friday from 8 am – 5 pm CST.

Consumers should contact their physician or pharmacy for further medical advice. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) FDA.

Link to FDA recall notification

Company Contact Information Consumers: Nostrum Laboratories, Inc.

Medical Affairs 816-308-4941
quality@nostrumpharma.com

Product Photos: Click here for product photos

About this Recall:

Nostrum is voluntarily recalling one (1) lot of metformin HCl ER tablets in the strength of 750 mg to the consumer level. This product is the generic equivalent to Glucophage® tablets. The recalled metformin HCl ER 750 mg tablets have been found to contain levels of nitrosamine impurities above the acceptable daily intake limit of 96 ng/day. This is an expansion of the recall initially announced on November 2, 2020.

What this means to you:

N-Nitrosodimethylamine (NDMA) is classified as a substance that could cause cancer based on results from lab tests. NDMA is a known environmental contaminant and is found in water and foods (including meats, dairy products, vegetables).

Metformin is used as an add-on to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. The recalled metformin ER 750 mg tablets are packaged in plastic bottles of 100 tablets with NDC 29033-056-01. The recalled tablets carry lot number MET200501 with expiration date 07/2022. The product can be identified as an off-white oblong tablet debossed with “NM7”.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

About this recall:

Nostrum Laboratories is voluntarily recalling one (1) lot of metformin hydrochloride (HCl) extended release (ER) tablets, USP 750 mg (generic equivalent to Glucophage® tablets) to the consumer level. The metformin HCl ER tablets, USP 750 mg have been found to contain levels of nitrosamine impurities above the acceptable daily intake (ADI) limit of 96 ng/day as published in the Food and Drug Administration (FDA) Guidance Document issued September 2020. This is an expansion of the recall initially announced on November 2, 2020.

Product Description: Metformin HCl Extended Release Tablets, USP 750 mg

NDC: 29033-056-01

Lot Number: MET200501

Expiry Date: 07/2022

Consumers with medical questions regarding this recall can contact Nostrum Medical Affairs by phone at 816-308- 4941 or email quality@nostrumpharma.com Monday through Friday from 8 am – 5 pm CST. Consumers should contact their physician or pharmacy for further medical advice.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report online.
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) FDA.

Link to FDA recall notification.

Company Contact Information Consumers: Nostrum Laboratories, Inc.

Medical Affairs 816-308-4941
quality@nostrumpharma.com

Product Photos: Click here for product photos.

About this Recall:

Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products with an expiration date from 12/31/2020 – 9/30/2022 to the consumer level. The product may be contaminated with the bacteria Burkholderia lata. This is an expansion of the recall initially announced in October 2020.

What this means to you:

Use of the contaminated product may lead to a mouth infection and, potentially, an infection in the body that requires antibacterial treatment. In the most at-risk populations, the use of the contaminated product may lead to life-threatening infections, such as pneumonia and bacteremia.

Consumers with questions regarding this recall can contact SAI by phone at 1-800-528-8537 or email at us.pcr@us.sunstar.com Monday to Friday from 8 am to 5 pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

For more information regarding this FDA Recall Notification, please refer to the FDA website. FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

About this recall:

Use of the contaminated product in an immunocompetent host may lead to oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the contaminated product may result in life-threatening infections, such as pneumonia and bacteremia.

To date, 29 adverse events have been reported to the manufacturer related to this recall. Affected patients tested positive for Burkholderia lata infections, usually found in sputum cultures, while under treatment for other serious medical conditions. Use of the contaminated product in patients with pre-existing respiratory conditions, including in those with coronavirus disease 2019 (COVID-19), is particularly unsafe.

The prescription oral rinse product, available through healthcare professionals (HCPs) only, is indicated for use as part of a professional program for the treatment of gingivitis and is packaged as follows:

1789P GUM® Paroex® is distributed in cases each containing 6 amber bottles of 16 fluid ounce (473 mL) chlorhexidine rinse. The bottle has a childproof cap and a 15 mL metered dosage cup, is safety sealed, and is decorated with a multiple-panel wrap-around label.
1788P GUM® Paroex® is distributed in cases each containing 24 amber bottles of 4 fluid ounce (118.25 mL) chlorhexidine rinse. The bottle has a childproof cap, is safety sealed, and is decorated with a multiplepanel wrap-around label.

Paroex was distributed nationwide to dental offices, dental distributors, pharmaceutical wholesalers, dental schools, and pharmacies.

SAI is notifying its direct distributors and customers by USPS Priority mail and is arranging for return of all recalled products. Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately. Sunstar is committed to delivering safe, fully compliant products of the highest quality and is taking necessary steps to prevent future occurrence of this issue.

Affected products and lot numbers follow below:

Product name: Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12%

Size/ Form: 16 fl.oz. amber bottles

NDC #: 052376-021-02

Product Code: 1789P

Lots Recalled: all lots with expiration date from December 31, 2020 through September 30, 2022.

Product name: Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% o Size/ Form: 4 fl.oz. Amber Bottles o NDC #: 052376-021-04 o Product Code: 1788P o Lots Recalled: all lots with expiration date from December 31, 2020 through September 30, 2022 Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration (FDA).

Link to FDA recall notification.

Company Contact Information Consumers: Sunstar Americas

1-800-528-8537
us.pcr@us.sunstar.com

Media: Greg Belair

847-794-4241
Greg.belair@us.sunstar.com

Product Photos: Click here for product photos.

About this Recall:

Avkare is voluntarily recalling 1 lot of sildenafil 100 mg tablets and 1 lot of trazodone 100 mg tablets to the consumer level. These products have been recalled due to a product mix-up of the listed 2 separate products inadvertently packaged together during bottling at a third party facility.

What this means to you:

Unintended intake of sildenafil may pose serious health risks to those with underlying medical issues. For example, sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels. Patients with diabetes, high blood pressure, or heart disease often take nitrates.

Unintended intake of trazodone may result in adverse health consequences such as somnolence/sedation, dizziness, constipation, and blurred vision. These adverse events may be more concerning in elderly patients due to an increased risk for falls and driving impairment. To date, Avkare has not received any reports of adverse events related to this recall.

Sildenafil, the active ingredient in Viagra®, which is a phosphodiesterase-5 (PDE-5) inhibitor, is used for the treatment of erectile dysfunction (ED) and is packaged in 100 count bottles (NDC 42291-748-01). Trazodone is indicated for the treatment of major depressive disorder and is packaged in 1,000 count bottles (NDC 42291-834- 10). The recalled lots of sildenafil 100 mg tablet (lot 36884 with an expiration date of 03/2022) and trazodone hydrochloride 100 mg tablet (lot 36783 with an expiration date of 06/2022) were distributed to distributors and wholesalers, and then further distributed nationwide. Avkare has notified its distributors and customers and is arranging for return of all recalled product.

Consumers with questions regarding this recall can contact Avkare at 1-855-361-3993 Monday through Friday (8 am – 4 pm CST). Consumers should contact their physician or healthcare provider (HCP) if they have experienced any problems that may be related to taking or using these drug products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration (FDA).

For more information regarding this FDA Recall Notification, please refer to the FDA website. FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

About this recall:
Avkare is voluntarily recalling one (1) lot of sildenafil 100 mg tablets and one (1) lot of trazodone 100 mg tablets to the consumer level. These products have been recalled due to a product mix-up of the listed two separate products inadvertently packaged together during bottling at a third party facility.

Product	Lot	Expiration date	Bottle count	NDC Number
Sildenafil Tablets, USP	36884	03/2022	100	42291-748-01
Trazodone Tablets, USP	36783	06/2022	1,000	42291-834-10

Sildenafil, the active ingredient in Viagra®, which is a (PDE-5) inhibitor, is used for the treatment of erectile dysfunction (ED) and is packaged in 100 count bottles (NDC 42291-748-01). Trazodone is indicated for the treatment of major depressive disorder (MDD) and is packaged in 1,000 count bottles (NDC 42291-834-10). The impacted lots of sildenafil 100 mg tablet (lot 36884 with an expiration date of 03/2022) and trazodone hydrochloride 100 mg tablet (lot 36783 with an expiration date of 06/2022) were distributed to distributors and wholesalers, and then further distributed nationwide.

Avkare has notified its distributors and customers and is arranging for return of all recalled product of the listed lots. Distributors that have any of the product which is being recalled should contact Customer Service at Avkare at 1-855-361-3993 or email customerservice@avkare.com to arrange for the return of the product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration (FDA).

Link to FDA recall notification.

Company Contact Information

Consumers: Customer Service at Avkare

1-855-361-3993
customerservice@avkare.com

Media: Clifton Stanfill

931-908-2192

Product Photos

Click here for product photos.

About this Recall:

Torrent is voluntarily recalling 1 lot of anagrelide capsules to the consumer level due to dissolution test failure detected during routine quality testing.

What this means to you:

Failed dissolution can result in a slower rate and amount of drug release leading to less anagrelide available in the body. For seriously ill patients with increased platelet counts, less available anagrelide could increase the risk for clotting or bleeding events such as a heart attack or stroke which could be life-threatening. To date, Torrent has not received any reports of adverse events related to this recall.

Anagrelide is used to treat a blood cell disorder called thrombocythemia (also called thrombocytosis), which occurs when your body produces too many platelet cells.

As the risk of harm may be higher if the treatment is stopped immediately without any alternative treatment, patients should contact their pharmacist or physician who can advise them about an alternative treatment before returning their medication.

The product being recalled is listed below and packaged in bottles. It can be identified by checking the product name, manufacturer details, and batch or lot number on the bottle containing the product.

NDC

Manufacturer

Product Description

Lot/Batch

Expiration Date

13668-462-01

Torrent

anagrelide capsule, USP 1 mg

100-count bottles

BFD1G001

12/2021

Torrent is arranging for return of all recalled products to Qualanex.

Consumers with medical questions regarding this recall or to report an adverse event can contact Torrent at:

1-800-912-9561 (live calls received 8:00 am – 5:00 pm Eastern Time, Monday to Friday; voicemail available 8:00 am – 5:00 pm Eastern Time, Monday to Friday).
Medinfo.Torrent@apcerls.com

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Any general questions regarding the return of this product should be directed to Qualanex at 1-888-424-4340 (live calls received 8 am – 5 pm Eastern Time, Monday to Friday).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration (FDA).

About this recall:
Torrent is voluntarily recalling one (1) lot of anagrelide capsules, USP to the consumer level due to dissolution test failure detected during routine quality testing.

Failed dissolution can result in a slower rate and extent of drug release leading to less anagrelide available in the body. For seriously ill patients with elevated platelet counts, less available anagrelide could increase the risk of clotting or bleeding events such as a heart attack or stroke which could be life-threatening. To date, Torrent has not received any reports of adverse events related to this recall.

Anagrelide is used to treat a blood cell disorder called thrombocythemia (also called thrombocytosis), which occurs when your body produces too many platelets.

The product subjected to the recall is listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details, and batch or lot number on the bottle containing the product.

NDC

Manufacturer

Product Description

Lot/Batch

Expiration Date

13668-462-01

Torrent

anagrelide capsule USP 1 mg,

100-count bottles

BFD1G001

12/2021

Anagrelide capsules, USP were distributed nationwide to Torrent’s wholesale distributor and retail customers. Torrent is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Torrent is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.

Consumers with medical questions regarding this recall or to report an adverse event can contact Torrent at:

1-800-912-9561 (live calls received 8:00 am – 5:00 pm Eastern Time, Monday to Friday; voicemail available 8:00 am – 5:00 pm Eastern Time, Monday to Friday).
Medinfo.Torrent@apcerls.com

2—1209-2020 Class 2 Anagrelide Capsules – Torrent Voluntary Nationwide Recall.

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Any general questions regarding the return of this product should be directed to Qualanex at 1-888-424-4340 (live calls received 8 am – 5 pm Eastern Time, Monday to Friday).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration.

Link to FDA recall notification

Company Contact Information

Consumers: Torrent Pharmaceuticals Limited

1-800-912-9561
Medinfo.Torrent@apcerls.com

Product Photos

Click here for product photos.

About this Recall:

MPM Medical is voluntarily recalling one (1) lot of Regenecare HA Hydrogel to the consumer level. Following two customer complaints of visible contamination, the product was found to be contaminated with the bacteria Burkholderia cepecia.

What this means to you:

Topical application of Regenecare HA Hydrogel contaminated with B. cepacia may result in local skin infections. For immunocompromised patients, including patients receiving chemotherapy and patients with cystic fibrosis, the skin infection is more likely to spread into the blood stream leading to life-threatening sepsis which can include symptoms such as fever, difficulty breathing, low blood pressure, fast heart rate, mental confusion, and possibly death. To date, MPM Medical has not received any reports of adverse events related to this recall.

Regenecare HA Hydrogel is an over-the-counter (OTC) product that contains 2% lidocaine and is used topically for temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations. It is packaged in 3 oz. plastic tubes and distributed in boxes of 12. The product can be identified by NDC 66977-107-03, and the lot number 41262 with expiration date 2021-01 debossed on the tube crimp as shown in the images provided at the hyperlink below. The recalled Regenecare HA Hydrogel lot (#41262) was distributed nationwide to wholesalers and healthcare facilities.

Patients in possession of the product which is being recalled should stop using. Consumers with questions regarding this recall can contact MPM Medical by phone at 1-800-232-5512 (toll-free) Monday through Friday between 7 AM and 5 PM CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product. For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

About this recall:
MPM Medical is voluntarily recalling one (1) lot of Regenecare® HA Hydrogel to the consumer level. Following two customer complaints of visible contamination, the product was found to be contaminated with the bacteria Burkholderia cepecia.

Risk Statement: Topical application of Regenecare HA Hydrogel contaminated with B. cepacia may result in local skin infections. For immunocompromised patients, including patients receiving chemotherapy and patients with cystic fibrosis, the skin infection is more likely to spread into the blood stream leading to life-threatening sepsis which can include symptoms such as fever, difficulty breathing, low blood pressure, rapid heart rate, mental confusion, and possibly death. To date, MPM Medical has not received any reports of adverse events related to this recall.

Regenecare HA Hydrogel is an over-the-counter (OTC) product that contains 2% lidocaine and is used topically for temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations. It is packaged in 3 oz. plastic tubes and distributed in boxes of 12. The product can be identified by NDC 66977-107-03 and the lot number 41262 with an expiration date 2021-01 debossed on the tube crimp as shown in the images provided at the below hyperlink. The recalled Regenecare HA Hydrogel lot (#41262) was distributed nationwide to wholesalers and healthcare facilities.

MPM Medical is notifying its distributors and customers by first class mail, electronic mail, and phone call and is arranging for return of all recalled product. Patients and healthcare facilities in possession of this product which is being recalled should stop using and dispensing.

Consumers with questions regarding this recall can contact MPM Medical by phone at 1-800-232-5512 (toll-free) Monday through Friday between 7 AM and 5 PM CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

MPM Medical is committed to delivering safe, fully compliant products of the highest quality and is taking necessary steps to prevent future occurrence of this issue.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration.

Link to FDA website.

Company Contact Information

Consumers:

MPM Medical, LLC
1-800-232-5512

Product Photos

To view product photos, use link to FDA website

About this Recall:

Nostrum Laboratories is recalling 2 lots of Metformin Hydrochloride (HCl) Extended Release (ER) Tablets, USP 500 mg and 2 lots of Metformin HCl ER Tablets, USP 750 mg. These products are being recalled as they contain levels of nitrosamine impurities above the Acceptable Daily Intake (ADI) limit of 96 ng/day.

What this means to you:

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods (including meats, dairy products, and vegetables). Nostrum has not received any reports of adverse events related to this recall.

Metformin HCl ER tablets are indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Product is packaged in HDPE bottles of 100 tablets, with NDC 29033-055-01 (500 mg) or NDC 29033-056-01 (750 mg). The 500 mg product can be identified as an off-white oblong tablet debossed with “NM5”, and the 750 mg product can be identified as an off-white oblong tablet debossed with “NM7”. The impacted lots of Metformin HCl ER Tablets, USP 500 mg and 750 mg can be found at the FDA Recall Notification links on the following page.

Consumers should consult a healthcare professional (HCP) to obtain a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their HCP. Consumers should contact their physician or HCP if they have experienced any problems that may be related to taking this drug product.

Consumers with medical questions regarding this recall can contact Nostrum Medical Affairs at phone number 816-308-4941 or via email at quality@nostrumpharma.com Monday through Friday from 8 am to 5 pm CST. Consumers should contact their physician or pharmacy for further medical advice.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration.

About this recall:
Nostrum Laboratories, Inc. is voluntarily recalling 2 lots of Metformin Hydrochloride (HCl) Extended Release (ER) Tablets, USP 500 mg and 2 lots of Metformin HCl ER Tablets, USP 750 mg to the consumer level. The Metformin HCl ER Tablets, USP 500 mg and 750 mg have been found to contain levels of nitrosamine impurities above the Acceptable Daily Intake (ADI) limit of 96 ng/day as published in the FDA Guidance Document issued September 2020.

Product Description	NDC	Lot Numbers	Expiry Dates
Metformin HCl Extended Release Tablets, USP 500 mg	29033-055-01	MET100201	05/2022
MET100401	05/2022
Metformin HCl Extended Release Tablets, USP 750 mg	29033-056-01	MET200101	05/2022
MET200301	05/2022

Nostrum is notifying its distributors by letter and is arranging for return of all recalled products. Pharmacies that have Metformin HCl ER Tablets, USP 500 mg or 750 mg which are being recalled should return to the place of purchase.

Consumers should consult a healthcare professional (HCP) to obtain a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their HCP. Consumers should contact their physician or HCP if they have experienced any problems that may be related to taking this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration.

Links to FDA recall notifications

Company Contact Information

Consumers: Nostrum Laboratories, Inc. Medical Affairs

816-308-4941
quality@nostrumpharma.com

About this Recall:
SAI is voluntarily recalling specific lots of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% with an expiration date from 6/30/2022 to 9/30/2022 to the consumer level. This product is being recalled as it may be contaminated with the bacteria Burkholderia lata.

What this means to you:
Use of the contaminated product in a person with a normal immune response may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the contaminated product may result in life-threatening infections, such as pneumonia and bacteremia. To date, no adverse events have been reported related to this recall.

The prescription oral rinse product, available through healthcare providers (HCPs) only, is indicated for use as part of a professional program for the treatment of gingivitis and is packaged as follows:

1789P GUM® Paroex® is distributed in cases each containing 6 amber bottles of 16 fluid ounce (473 mL) chlorhexidine rinse. The bottle has a childproof cap and a 15 mL metered dosage cup, is safety sealed, and is decorated with a multiple-panel wrap-around label.

1788P GUM® Paroex® is distributed in cases each containing 24 amber bottles of 4 fluid ounce (118.25 mL) chlorhexidine rinse. The bottle has a childproof cap, is safety sealed, and is decorated with a multiple-panel wrap-around label.

The product can be identified as shown in the images linked here.

Paroex was distributed nationwide to dental offices, dental distributors, pharmaceutical wholesalers, dental schools, and pharmacies.

SAI is notifying its direct distributors and customers by USPS Priority mail and is arranging for return of all recalled products. Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately.

Consumers with questions regarding this recall can contact SAI by phone at 1-800-528-8537 or email at us.pcr@us.sunstar.com Monday through Friday from 8 am to 5 pm CST. Consumers should contact their physician or HCP if they have experienced any problems that may be related to using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Sunstar is committed to delivering safe, fully compliant products of the highest quality and is taking necessary steps to prevent future occurrence of this issue.

This recall is being conducted with the knowledge of the US Food and Drug Administration (FDA).

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

About this recall:
Sunstar Americas, Inc. (SAI) is voluntarily recalling specific lots of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% with an expiration date from 6/30/2022 to 9/30/2022 to the consumer level. This product is being recalled as it may be contaminated with the bacteria Burkholderia lata.

Use of the defective product in an immunocompetent person may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia. To date, no adverse events have been reported related to this recall.

The prescription oral rinse product, available through healthcare providers (HCPs) only, is indicated for use as part of a professional program for the treatment of gingivitis and is packaged as follows:

1789P GUM® Paroex® is distributed in cases each containing 6 amber bottles of 16 fluid ounce (473 mL) chlorhexidine rinse. The bottle has a childproof cap and a 15 mL metered dosage cup, is safety sealed, and is decorated with a multiple-panel wrap-around label.
1788P GUM® Paroex® is distributed in cases each containing 24 amber bottles of 4 fluid ounce (118.25 mL) chlorhexidine rinse. The bottle has a childproof cap, is safety sealed, and is decorated with a multiple-panel wrap-around label.

The product can be identified as shown in the images linked at the bottom of this memo.

Paroex was distributed nationwide to dental offices, dental distributors, pharmaceutical wholesalers, dental schools, and pharmacies.

Consumers with questions regarding this recall can contact SAI by phone at 1-800-528-8537 or email at us.pcr@us.sunstar.com Monday through Friday from 8 am to 5 pm CST. Consumers should contact their physician or HCP if they have experienced any problems that may be related to using this drug product.

Affected products and lot numbers are listed below:

Product name: Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% NDC 052376-021-02 P/N 1789P 16 fl. oz.


Lot #	Expiration Date	Lot #	Expiration Date	Lot #	Expiration Date
C170FY	6/30/22	C191KT	7/31/22	C205BL	7/31/22
C170FZ	6/30/22	C191KU	7/31/22	C205BM	7/31/22
C170GA	6/30/22	C191KW	7/31/22	C205BN	7/31/22
C170GB	6/30/22	C191KX	7/31/22	C219DS	8/31/22
C170GC	6/30/22	C191KY	7/31/22	C240GM	9/30/22
C177GP	6/30/22	C198LJ	7/31/22	C219DK	8/31/22
C177GQ	6/30/22	C198LK	7/31/22	C219DL	8/31/22
C177GR	6/30/22	C198LL	7/31/22	C219DM	8/31/22
C240GP	9/30/22	C198LM	7/31/22	C219DN	8/31/22
C240GQ	9/30/22	C205BH	7/31/22	C219DP	8/31/22
C240GR	9/30/22	C205BJ	7/31/22	C219DQ	8/31/22
C191KS	7/31/22	C205BK	7/31/22	C219DR	8/31/22

3—1028-2020 Class 2 Paroex – Sunstar Voluntary Nationwide Recall.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Sunstar is committed to delivering safe, fully compliant products of the highest quality and is taking necessary steps to prevent future occurrence of this issue.

This recall is being conducted with the knowledge of the US Food and Drug Administration (FDA).

About Sunstar Americas Inc.

Sunstar Americas, Inc., a member of the Sunstar Group of companies, is a global organization headquartered in Switzerland that is a leader in the oral care industry and the manufacturer and distributor of the GUM and Butler Brands.

For more information:

us.pcr@us.sunstar.com

Contact Sunstar: Phone: 1-800-528-8537

Link to FDA recall notification

Company Contact Information

Consumers: Sunstar Americas, Inc.

1-800-528-8537
us.pcr@us.sunstar.com

Product Photos

Click here for product photos

About this Recall:

Marksans Pharma is voluntarily expanding its earlier initiated recall on June 5, 2020 to include an additional 76 unexpired lots of Metformin Hydrochloride (HCl) Extended-Release (ER) Tablets, USP 500 mg and 750 mg to the consumer level.

Marksans performed N-Nitrosodimethylamine (NDMA) testing of unexpired identified marketed lots and observed that NDMA content in some lots was exceeding the acceptable daily intake (ADI) limit of 96 ng/day, therefore, out of an abundance of caution, an additional 76 lots are being recalled.

What this means to you:

NDMA is classified as a substance that could cause cancer based on results from laboratory tests. NDMA is a known environmental contaminant found in water and foods (such as meats, dairy products, and vegetables). Marksans has not received any reports of adverse events that have been related to this recall.

Metformin HCl ER Tablets, USP 500 mg and 750 mg are indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. It is packaged in bottles with the following NDC numbers in different packing configurations.

Metformin HCl ER Tablets, USP 500 mg:

90 counts: 49483-0623-09
100 counts: 49483-0623-01
500 counts: 49483-0623-50
1,000 counts: 49483-0623-10

Metformin HCl ER Tablets, USP 750 mg:

100 counts: 49483-0624-01

The affected Metformin HCl ER Tablets, USP 500 mg, are white to off white, capsule shaped, biconvex tablets, debossed with ‘101’ on one side and plain on the other side. The impacted Metformin HCl ER Tablets, USP 750 mg, are white to off white, capsule shaped, biconvex tablets, debossed with ‘102’ on one side and plain on the other side.

For a complete listing of recalled lot numbers and expiration dates, view the FDA recall notification.

Consumers with questions regarding this recall and return can contact Ms. Irene McGregor (Vice President, Regulatory Affairs) of Time-Cap Labs by phone number 631-753-9090, ext. 160, Monday to Friday 8 am to 5 pm EST or by e-mail at imcgregor@timecaplabs.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Link to initial FDA recall notification

Link to expanded FDA recall notification

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

About this recall:
Marksans Pharma is voluntarily expanding its earlier initiated recall on June 5, 2020 to include an additional 76 unexpired lots of Metformin Hydrochloride (HCl) Extended-Release (ER) Tablets, USP 500 mg and 750 mg to the consumer level. Marksans performed N-Nitrosodimethylamine (NDMA) testing of unexpired identified marketed lots and observed that the NDMA content in some lots was exceeding the acceptable daily intake limit (ADI) of 96 ng/day, therefore, out of an abundance of caution, an additional 76 lots are being recalled.

Metformin HCl ER Tablets, USP 500 mg and 750 mg are indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. It is packaged in HDPE bottles with the following NDCs in different packing configurations:

Metformin HCl ER Tablets, USP 500 mg:

90 counts: 49483-0623-09
100 counts: 49483-0623-01
500 counts: 49483-0623-50
1,000 counts: 49483-0623-10

Metformin HCl ER Tablets, USP 750 mg:

100 counts: 49483-0624-01

For a complete listing of recalled lot numbers and expiration dates, view the FDA recall notification.

Metformin HCl ER Tablets, USP 500 mg and 750 mg were distributed by Time-Cap Labs nationwide in the United States (US) to wholesalers who further distributed to pharmacies. Marksans is notifying its distributors and customers by issuing a notification letter and press release and is arranging for return/replacement of recalled product lots. Distributors and customers that have affected lots of metformin HCl ER tablets that are being recalled should return to the place of purchase. The lot number can be located on the side panel of bottle labels as well as shipper/case labels.

Consumers taking these recalled product lots of metformin ER tablets are instructed by the FDA to continue taking it, until a doctor or pharmacist gives them a replacement or an alternative treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their healthcare professional (HCP). Consumers should contact their physician or HCP if they have experienced any problems that may be related to taking or using this drug product. Consumers with questions regarding this recall and return can contact Ms. Irene McGregor (Vice President, Regulatory Affairs) of Time-Cap Labs by phone number 631-753-9090, ext. 160, Monday to Friday 8 AM to 5 PM EST or by e-mail at imcgregor@timecaplabs.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the US Food and Drug Administration (FDA).

Company Contact Information

Consumers: Ms. Irene McGregor (Vice President, Regulatory Affairs) of Time-Cap Labs, Inc.

631-753-9090; ext. 160
imcgregor@timecaplabs.com

Product Photos

Click here for product photos

About this Recall:

Sun Pharma is voluntarily recalling 1 lot of Riomet ER (metformin HCl for ER oral suspension), 500 mg per 5 mL, to the consumer level. The reason for the recall is due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the acceptable daily intake (ADI) limit established by the United States (US) Food and Drug Administration (FDA).

NDMA is classified as a substance that could cause cancer based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods, such as meats, dairy products, and vegetables. To date, Sun Pharma has not received any reports of adverse events related to this recall.

What this means to you:

Patients taking Riomet ER (metformin HCl for ER oral suspension), 500 mg per 5 mL are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the US FDA, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their healthcare professionals (HCPs). Please visit the agency’s website for more information.

Riomet ER (metformin HCl for ER oral suspension) is a prescription oral medication indicated as an add-on to diet and exercise to improve blood glucose control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Riomet ER, when reconstituted, is packaged in a 16 oz. (473 mL) round bottle. Each carton contains 1 bottle of drug pellets, 1 bottle of diluent, and 1 dosing cup.

The product can be identified by the bottles or carton labeled as Riomet ER containing the specific NDC, lot number, and expiration date found at the FDA Recall Notification link below.

Consumers with questions regarding this recall can contact Sun Pharma by calling 1-800-818-4555 Monday through Friday between 8:00 am to 5:00 pm EST or emailing drug.safetyUSA@sunpharma.com. Consumers should contact their physician or HCP if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

About this recall:

Sun Pharma is voluntarily recalling 1 lot of Riomet ER™ (metformin hydrochloride [HCl] for extended-release [ER] oral suspension), 500 mg per 5 mL, to the consumer level. The reason for the recall is due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the acceptable daily intake (ADI) limit established by the United States (US) Food and Drug Administration (FDA).

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods, such as meats, dairy products, and vegetables. To date, Sun Pharma has not received any reports of adverse events related to this recall.

Riomet ER (metformin HCl for ER oral suspension) is a prescription oral medication indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Riomet ER, when reconstituted, is packaged in a 16 oz. (473 mL) round bottle. Each carton contains 1 bottle of drug pellets, 1 bottle of diluent, and 1 dosing cup. The affected Riomet ER is the following lot:

Product Name	Lot Number	NDC Number	Expiration Date	Number of Units
Riomet ER (metformin HCL for oral suspension), 500 mg per 5 mL	AB06381	10631-091-17	10/2021	747 cartons

The product can be identified by the bottles or carton labeled as Riomet ER (metformin HCl for ER oral suspension), containing the specific lot number and expiration date referenced above or on the product photos linked below. The product was distributed nationwide to wholesale customers.

Sun Pharma is notifying its distributors and customers through its third-party Recall Coordinator (Inmar), via FedEx standard overnight shipping and will arrange for return of all recalled products.

Distributors and retailers that have Riomet ER (metformin HCl for ER oral suspension), which is being recalled, should stop distributing and return it to the place of purchase or as directed in the recall notification.

Consumers with questions regarding this recall can contact Sun Pharma by calling 1-800-818-4555 Monday through Friday between 8:00 am to 5:00 pm EST or e-mailing drug.safetyUSA@sunpharma.com. Consumers should contact their physician or HCP if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the US FDA.

Link to FDA recall notification

Company Contact Information

Consumers: Sun Pharma

1-800-818-4555
Drug.safetyUSA@sunpharma.com

Media: Vinita Alexander

1-609-720-8197
vinita.alexander@sunpharma.com

Product Photos

Click here for product photos

About this Recall:

Bayshore Pharmaceuticals is voluntarily recalling one (1) lot of metformin HCl ER tablets, 500 mg, and one (1) lot of metformin HCl ER tablets, 750 mg, within expiration to the consumer level. The recall is due to N-nitroso-dimethylamine (NDMA) levels above the acceptable daily intake (ADI) limit. This product was manufactured by Beximco in June 2019, for United States (US) distribution by Bayshore.

What this means to you:

NDMA is a substance that could cause cancer based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods (such as meats, dairy products, and vegetables). The impacted metformin ER tablets can be identified by the NDC number found on the product label and the product lot number. The recalled NDC and lot numbers are listed on the FDA Recall Notification at the link below. Patients who have received impacted lots of metformin ER tablets are advised by the manufacturer to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the FDA, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their healthcare professionals.

Patients with medical-related questions, who wish to report an adverse event or quality issue about the products being recalled should contact Bayshore by phone at 877-372-6093.

Patients wishing to return product may contact Bayshore’s product recall processor, Qualanex, to obtain instructions and a return kit for returning their medication:

Contact Qualanex at 888-504-2013
Qualanex will provide the materials needed to return their medication and instructions for reimbursement

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

About this recall:

Bayshore Pharmaceuticals is voluntarily recalling one (1) lot of Metformin Hydrochloride (HCl) Extended-Release (ER) Tablets USP, 500 mg, in 1000-count bottles and one (1) lot of Metformin HCl ER Tablets USP, 750 mg, in 100-count bottles within expiry to the consumer level due to the detection of N-Nitrosodimethylamine (NDMA) levels above the acceptable daily intake (ADI) Limit. This product was manufactured by Beximco in June 2019, for United States (US) distribution by Bayshore.

Bayshore was notified by the US Food and Drug Administration (FDA) that 1 lot (lot #18657) of metformin HCl ER tablets, 750 mg, was tested and showed NDMA levels in excess of the ADI limit and recommended recall of the 1 tested lot.

Bayshore has agreed to recall this lot, and out of an abundance of caution, the company has tested samples from 8 lots of metformin HCl ER tablets manufactured using same active pharmaceutical ingredient (API) lot of the failed lot. Out of 8 lots, 1 lot (lot #18657) of metformin HCl ER tablets, 750 mg, and 1 lot (lot #18641) of metformin HCl ER tablets, 500 mg, have showed NDMA levels in excess of the ADI limit. As a result, Bayshore has decided to recall the 2 lots. To date, neither Bayshore nor Beximco have received any reports of adverse events related to use of the product.

Metformin HCl ER tablets USP, 500 mg and 750 mg, are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Patients who have received impacted lots of metformin ER tablets are advised by the manufacturer to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the FDA, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their healthcare professionals. Please visit the agency’s website for more information.

The metformin HCl ER tablets, 500 mg and 750 mg, lots subject to the recall are identified in the table below.

Product Name	Strength	Bottle Size	NDC Number	Lot Number	Expiration
Metformin HCl ER Tablets USP, 500 mg	500 mg	1,000 count	76385-0128-10	18641	May 2021
Metformin HCl ER Tablets USP, 750 mg	750 mg	100 count	76385-0129-01	18657	May 2021

The impacted metformin HCl ER tablet lots were distributed nationwide in the US by Bayshore directly to wholesalers and distributors. Bayshore is in the process of notifying its customers impacted by this recall by phone and through recall notification and is arranging for return of the recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.

Customers and patients with medical-related questions, who wish to report an adverse event or quality issue about the products being recalled should contact Bayshore by phone at 877-372-6093.

Patients wishing to return product may contact Bayshore’s product recall processor, Qualanex, to obtain instructions and a return kit for returning their medication:

Contact Qualanex at 888-504-2013
Qualanex will provide the materials needed to return their medication and instructions for reimbursement

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Patient safety and product quality are critical to Bayshore. Bayshore will continue to partner with, and regularly update, all relevant regulatory authorities as relevant information becomes available.

Company Contact Information

Consumers: Qualanex, Bayshore Pharmaceuticals LLC Information

888-504-2013
877-372-6093

Product Photos

For Product photos please refer to the FDA Link.

About this Recall:

Ferring Pharmaceuticals US is voluntarily recalling all lots on the market of DDAVP nasal spray 10 mcg/0.1mL, desmopressin acetate nasal spray 10 mcg/0.1mL, and Stimate® nasal spray 1.5 mg/mL. These products are being recalled due to amounts of desmopressin higher than specified. These results were obtained during routine testing.

What this means to you:

The risks associated with higher than specified amounts of desmopressin are due to abnormally low levels of sodium in the blood (e.g., hyponatremia) which could eventually lead to seizure, coma, and death. To date, Ferring has not received an increase in adverse event reports due to increased concentrations of desmopressin from users of the nasal spray. However, a single non-fatal adverse event potentially associated with this issue was reported during the timeframe that the impacted product was distributed.

DDAVP nasal spray and desmopressin nasal spray are both indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus as well as for the management of temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Stimate nasal spray is indicated for the treatment of patients with hemophilia A with Factor VIII coagulant activity levels greater than 5% and for the treatment of patients with mild to moderate classic von Willebrand’s disease (Type I) with Factor VIII levels greater than 5%.

The impacted product names, including the batch numbers and expiration dates, are available on the FDA Recall Notification, listed at the link on the following page. Patients and consumers can contact their physician or healthcare provider with any questions related to this recall.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

About this recall:
Ferring Pharmaceuticals is voluntarily recalling all lots on the market of DDAVP® Nasal Spray 10 mcg/0.1 mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, and Stimate® Nasal Spray 1.5 mg/mL listed in the table on the following page to the consumer level. These products are being recalled due to superpotency or amounts of desmopressin higher than specified. These out of specification results were obtained during routine testing.

The risks associated with higher than specified amounts of desmopressin relate to abnormally low levels of sodium in the blood (e.g., hyponatremia) which could eventually lead to seizure, coma, and death. To date, Ferring has not received an increase in adverse event reports due to increased concentrations of desmopressin from users of the nasal spray. A single non-fatal adverse event potentially associated with this issue was reported in the US during the timeframe that the affected product was distributed.

Ferring is notifying its distributors and wholesale customers by letter and asking them to check for impacted product and to return unused product through directions provided in the recall letter. The affected product name, including the batch numbers and expiration dates are found in the table below.

DDAVP® Nasal Spray 10 mcg/0.1 mL, 5mL

Lot	Expiration	NDC Number
N14695F	08-2020	55566-2500-00
N15627C	10-2020	55566-2500-00
P11319P	01-2021	55566-2500-00
P11706F	04-2021	55566-2500-00
R11842C	03-2022	55566-2500-00
R13637E	06-2022	55566-2500-00

Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5 mL

Lot	Expiration Date	NDC Number
N14695F	08-2020	55566-2500-00
N14695S	08-2020	69918-0501-05
N15627G	10-2020	69918-0501-05
N15627GA	10-2020	69918-0501-05
P10422A	01-2021	69918-0501-05
P10422AA	01-2021	69918-0501-05
P10430G	03-2021	69918-0501-05
P11319M	01-2021	69918-0501-05
P12969H	05-2021	69918-0501-05
P12969IR	05-2021	69918-0501-05
P13216G	05-2021	69918-0501-05
P13216P	05-2021	69918-0501-05
R11842A	03-2022	69918-0501-05
R11842S	03-2022	69918-0501-05
R12630A	05-2022	69918-0501-05
R13071H	04-2022	69918-0501-05

Stimate® Nasal Spray 1.5 mg/mL, 2.5 mL

Lot	Expiration Date	NDC Number
N14134C	07-2020	00053-6871-00
N15378G	09-2020	00053-6871-00
N17445N	12-2020	00053-6871-00
P11326AA	02-2021	00053-6871-00
P11326C	02-2021	00053-6871-00
P13209L	04-2021	00053-6871-00
P13212H	06-2021	00053-6871-00
P13755A	06-2021	00053-6871-00
P13756P	08-2021	00053-6871-00
R11845A	04-2022	00053-6871-00
R13271A	04-2022	00053-6871-00
R13648A	06-2022	00053-6871-00
R14101A	07-2022	00053-6871-00
R14667A	08-2022	00053-6871-00
R15953C	09-2022	00053-6871-00

Distributors/wholesalers with questions regarding the recall should call Stericycle at 1-888-228-5053.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the US Food and Drug Administration.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. In the United States, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and orthopedics. For more information, call 1-888-FERRING (1-888-337-7464); visit www.FerringUSA.com.

Link to FDA recall notification

Company Contact Information

Consumers:

1-888-337-7464

Media: Patrick Gorman

(862) 286-5035
patrick.gorman@ferring.com

About this Recall:

Lupin Pharmaceuticals is voluntarily recalling all batches of Metformin ER Tablets, 500 mg and 1,000 mg to the consumer level. As part of the ongoing evaluation and communication with the Food & Drug Administration (FDA), additional testing showed that certain tested batches were above the acceptable daily intake (ADI) limit for the impurity N-Nitrosodimethylamine (NDMA). Out of an abundance of caution, the company is recalling all batches of metformin ER tablets in the strengths of 500 mg and 1,000 mg in the United States (US).

What this means to you:

NDMA is a substance that could cause cancer based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods (including meats, dairy products, and vegetables). Metformin ER tablets are a prescription oral medication used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. The recalled NDCs are available at the FDA Recall Notification link found in the box on the following page.

Patients taking recalled metformin ER tablets, 500 mg or 1,000 mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the US FDA, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their healthcare providers. Please visit the agency’s website for more information.

Consumers with questions regarding this recall should contact Inmar Rx Solutions at (855) 532-1856 Monday through Friday 9:00 AM to 5:00 PM EST. For reimbursement, please have the recalled NDCs returned to Inmar Rx Solutions; the NDC number can be found on the top of the bottle label.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

About this recall:
Lupin Pharmaceuticals is voluntarily recalling all batches of Metformin Hydrochloride (HCl) Extended-Release (ER) Tablets USP, 500 mg and 1000 mg to the consumer level. As part of the ongoing assessment and continuation of dialog with the Food & Drug Administration (FDA), additional analysis revealed that certain tested batches were above the acceptable daily intake (ADI) limit for the impurity N-Nitrosodimethylamine (NDMA). Out of an abundance of caution, the company is recalling all batches of Metformin HCl ER Tablets USP, 500 mg and 1,000 mg in the United States (US). To date, Lupin Pharmaceuticals has not received any reports of adverse events related to this recall.

Metformin ER is a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Metformin ER tablets 500 mg and 1,000 mg are packaged in 60, 90, and 100 count bottles and were distributed nationwide in the US to wholesalers, distributors, drug chain pharmacies, mail order pharmacies, and supermarkets. The recalled NDCs are included in the table below:

Product	Strengths	NDC	Distribution Dates
Metformin HCI ER Tablets, USP	500 mg	68180-0338-01	11/21/2018 - 05/27/2020
Metformin HCI ER Tablets, USP	1,000 mg	68180-0339-09	11/21/2018 - 05/27/2020
Metformin HCI ER Tablets, USP	500 mg	68180-0336-07	11/05/2018 - 05/22/2020
Metformin HCI ER Tablets, USP	1,000 mg	68180-0337-07	11/05/2018 - 05/22/2020

Lupin Pharmaceuticals is notifying its wholesalers, distributors, drug chain pharmacies, mail order pharmacies, and supermarket customers by phone and through recall notification and is arranging for the return of all the recalled product NDCs.

Patients taking Metformin HCl ER Tablets, USP 500 mg or 1,000 mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the US FDA, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their healthcare professionals. Please visit the agency’s website for more information.

Wholesalers, distributors, and retailers that have Metformin HCl ER Tablets USP, 500 mg and 1,000 mg that are being recalled should discontinue distribution of the recalled product NDCs immediately and return it to Inmar Rx Solutions, 635 Vine St., Winston Salem, NC 27101 (phone 855-532-1856).

Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (855) 532-1856 Monday through Friday 9:00 AM to 5:00 PM EST. For reimbursement, please have the recalled NDCs returned to Inmar Rx Solutions; the NDC number can be found on the top of the bottle label.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the US FDA.

Link to FDA recall notification

Company Contact Information

Consumers: Inmar, Rx Solutions, Inc.

(855) 532-1856

Media: Arvind Bothra

arvindbothra@lupin.com

Product Photos

Click here for product photos.

About this recall:

Granules Pharmaceuticals is voluntarily recalling twelve (12) lots of Metformin ER Tablets, 750 mg, supplied in 100 and 500 count bottles within expiration to the consumer level due to the detection of N-Nitrosodimethylamine (NDMA) levels above the acceptable daily intake (ADI) limit.

Granules’ test results showed NDMA levels above the FDA’s acceptable limit in one (1) out of the twelve (12) batches distributed in the United States (US). All other batches continue to remain within the required limits. Out of abundance of caution, Granules Pharmaceuticals has decided to voluntarily recall all twelve (12) of the distributed lots within expiration of metformin ER tablets, 750 mg.

Granules’ metformin immediate-release (IR) tablets in the strengths of 500 mg, 850 mg, and 1,000 mg as well as their metformin ER tablets in the 500 mg strength are not impacted by this recall.

What this means to you:

Metformin ER tablets, 750 mg, are used as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Details for identifying the recalled lots are available at the FDA Recall Notification link found on the following page.

Patients with questions regarding this recall or wishing to return product may contact Inmar Pharmaceutical Services recall processor for instructions and a return kit for returning their medication:

Contact Inmar at 888-985-9117 (hours of operation: 9 AM to 5 PM Eastern Time, Monday through Friday) or email Inmar at: rxrecalls@inmar.com
Inmar will provide the materials needed to return medication and instructions for reimbursement

If you would like to report any adverse reactions or quality problems experienced with the use of this product you may contact Granules Drug Safety by phone at 1-877-770-3183 Monday through Friday, 8:00 AM to 8:00 PM EST, or via email at drugs.safety@granulesindia.com.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

About this recall:
Granules Pharmaceuticals, Inc., is voluntarily recalling twelve (12) lots of Metformin Hydrochloride (HCl) Extended-Release (ER) Tablets USP, 750 mg, 100 and 500 count bottles within expiry to the consumer level due to the detection of N-Nitrosodimethylamine (NDMA) levels above the acceptable daily intake limit.

Granules’ test results showed NDMA levels above the FDA’s acceptable limit in one (1) out of the twelve (12) batches distributed to the United States (US) market. All other batches continue to remain within the specifications. Out of abundance of caution, Granules Pharmaceuticals has decided to voluntarily recall all twelve (12) of the distributed lots within expiry of Metformin HCl ER Tablets USP, 750 mg from the market.

Granules Pharmaceuticals, Inc. has not received any reports of adverse events that have been confirmed to be directly related to this recall as of the date of this letter.

Granules’ Metformin HCl Immediate-Release (IR) Tablets USP, 500 mg, 850 mg, & 1,000 mg and Metformin HCl ER Tablets USP, 500 mg are not affected by this recall.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Metformin HCl ER Tablets USP, 750 mg are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. The metformin ER tablets, 750 mg, lots subject to the recall are identified below:

Metformin HCl ER Tablets USP, 750 mg

NDC Number	Bottle Count	Lot/Expiration
70010-0492-01	100 count	4920003A/May-21 4920004A/Jun-21 4920005A/Jun-21 4920009A/Nov-21 4920010A/May-22 4920011A/Jun-22 4920012A/Jun-22 4920013A/Jul-22
70010-0492-05	500 count	4920014A/Jul-22 4920015A/Aug-22 4920016A/Jan-23 4920005B/Jun-21

The affected metformin ER tablets, 750 mg, lots were distributed nationwide in the US directly to distributors and retailers. Granules Pharmaceuticals is in the process of notifying its distributers and customers affected by this recall via mail (FedEx standard overnight) by mailing a recall notification letter and is arranging for return of the entire recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.

Customers and patients with questions regarding this recall or wishing to return product may contact Inmar Pharmaceutical Services product recall processor to obtain instructions and a return kit for returning their medication:

Contact Inmar at 888-985-9117 (hours of operation: 9 AM to 5 PM Eastern Time, Monday through Friday) or email Inmar at: rxrecalls@inmar.com
Inmar will provide the materials needed to return their medication and instructions for reimbursement
If you would like to report any adverse reactions or quality problems experienced with the use of this product you may contact Granules Drug Safety by phone at 1-877-770-3183 Monday through Friday, 8:00 AM to 8:00 PM EST, or via email at drugs.safety@granulesindia.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the US Food and Drug Administration (FDA).

Link to FDA Recall Notification

Company Contact Information

Consumers: Inmar, Pharmaceutical Services

888-985-9117
rxrecalls@inmar.com

Media: Mary D Villalona, Director, Quality

571-665-2914
mary.villalona@granulespharma.com

Product Photos

Click here to view product photos

About this Recall:

GSK Consumer Healthcare is voluntarily recalling to the retail level two (2) lots of Children’s Robitussin® Honey Cough and Chest Congestion DM and one (1) lot of Children’s Dimetapp® Cold and Cough (listed at the FDA Recall Notification link below), as the packages contain incorrect dosing cups. During the review of the packaging for these products, GSK discovered that the dosing cups for the Children’s Robitussin® Honey product are missing the 5 mL and 10 mL graduations, and the dosing cups for the Children’s Dimetapp® product are missing the 10 mL graduation. The dosing cups packaged with both products only have the 20 mL graduation.

What this means to you:

There is a potential risk of accidental overdose if caregivers dispensing the syrup do not notice the differences between the graduations printed on the dosing cups and the indicated amounts to be administered (as directed in the Instructions for Use). Children’s Robitussin Honey Cough & Chest Congestion DM contains 10 mg dextromethorphan and guaifenesin 100 mg per 10 mL and is labeled for children 4 years and older and for adults. Children’s Dimetapp Cold & Cough contains 2 mg brompheniramine, 10 mg dextromethorphan, and 5 mg phenylephrine per 10 mL, and is labeled for children 6 years and older and adults. Symptoms of overdose of either product may include any of the following: impaired coordination; increase or decrease in energy; elevation in blood pressure, heart rate, or respiration; severe dizziness or drowsiness; slow heart rate; fainting; restlessness; seizure; decreased respiration; nausea; vomiting; constipation; diarrhea; abdominal pain; visual and hearing hallucinations; and urinary retention. As of the date of the recall, GSK had not received any adverse events related to this recall or consumer complaints about the incorrect dosing cups supplied with the product.

Consumers with questions regarding this recall or to report an adverse experience please call 1-800-762-4675, Monday through Friday, 8:00 AM – 6:00 PM EST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

About this recall:
GSK Consumer Healthcare is voluntarily recalling to the retail level two (2) lots (listed below) of Children’s Robitussin® Honey Cough and Chest Congestion DM and one (1) lot of Children’s Dimetapp® Cold and Cough, due to the inclusion of incorrect dosing cups. During the review of the packaging documents for these products, GSK discovered that the dosing cups for the Children’s Robitussin® Honey product are missing the 5 mL and 10 mL graduations, while the dosing cups for the Children’s Dimetapp® product are missing the 10 mL graduation. The dosing cups packaged with both products only have the 20 mL graduation.

There is a potential risk of accidental overdose if caregivers dispensing the syrup do not notice the discrepancies between the graduations printed on the dosing cups and the indicated amounts to be administered (as directed in the Instructions for Use). Children’s Robitussin Honey Cough & Chest Congestion DM contains 10 mg dextromethorphan HBr USP and guaifenesin USP 100 mg per 10 mL, and is labeled for children 4 and older, as well as adults. Children’s Dimetapp Cold & Cough contains 2 mg brompheniramine maleate USP, 10 mg dextromethorphan HBr USP, and 5 mg phenylephrine HCl USP per 10 mL, and is labeled for children 6 and older, as well as adults. Symptoms of overdose of either product may include any of the following: impaired coordination; brain stimulation causing increase in energy, elevation in blood pressure, heart rate, and respiration; a lack of energy and enthusiasm; severe dizziness or drowsiness; slow heart rate; fainting; psychotic behavior; restlessness; seizure; decreased respiration; nausea; vomiting; constipation; diarrhea; abdominal pain; visual and hearing hallucinations; urinary retention. As of the date of the recall announcement, GSK Consumer Healthcare has not received any adverse events related to these products or consumer complaints regarding the incorrect dosing cups supplied with the product. The recall is limited to the three (3) lots listed below:

Drug name	NDC Number	Lots(Expiration)
Children’s Robitussin® Honey Cough and Chest Congestion DM (4 oz)	00031-8760-12	02177 (Jan 2022) 02178 (Jan 2022)
Children’s Dimetapp® Cold and Cough (8 oz)	00031-2234-19	CL8292 (Sep 2021)

These lots were distributed nationwide between February 5, 2020 and June 3, 2020 within the United States (US). GSK Consumer Healthcare has notified wholesalers, distributors, and retailers to arrange for return of any recalled product. Wholesalers, distributors, and retailers with an existing inventory of the lots being recalled should stop distribution and quarantine these lots immediately. Wholesalers, distributors, and retailers that have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product from them.

Consumers with questions regarding this recall or to report an adverse experience please call 1-800-762-4675, Monday through Friday, 8:00 AM – 6:00 PM EST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the US Food and Drug Administration (FDA).

Company Contact Information

Consumers: GSK Contact Center

1-800-762-4675

Product Photos

For photos of this recall, please refer to the FDA link.

About this Recall:

Lupin Pharmaceuticals is voluntarily recalling 1 lot of Metformin ER Tablets, 500 mg, to the consumer level.

FDA testing showed that this lot had higher levels than the Acceptable Daily Intake limit for the impurity N-Nitrosodimethylamine (NDMA).

What this means to you:

The FDA Recall Notification linked below lists the recalled NDC and lot number. The product can be identified by the NDC and lot number listed on the side of the bottle label. Metformin ER tablets were distributed nationwide in the United States (US) to wholesalers, distributors, and mail order pharmacies.

Patients with recalled metformin ER tablets are advised by the manufacturer to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the US Food & Drug Administration (FDA), it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their healthcare provider.

Consumers with questions about this recall should contact Inmar Rx Solutions at (855) 532-1856, Monday through Friday, 9:00 AM to 5:00 PM EST. For reimbursement, please have the recalled lot returned to Inmar Rx Solutions; the lot number can be found on the side of the bottle.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

About this recall:
Lupin Pharmaceuticals Inc. is voluntarily recalling Metformin Hydrochloride Extended-Release (ER) Tablets USP (generic equivalent of Fortamet®), 500 mg, lot G901203, to the consumer level. FDA analysis revealed that this lot exceeded the Acceptable Daily Intake (ADI) limit for the impurity N-Nitrosodimethylamine (NDMA). To date, Lupin has not received any reports of adverse events related to this recall.

Metformin ER is a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. The product is packaged in a bottle containing 60 tablets with NDC 68180-0336-07. The impacted lot of metformin ER tablets 500 mg is listed in the below table:

Product Name	NDC	Lot Number	Expiration
Metformin Hydrochloride Extended-Release Tablets USP, 500mg	68180-0336-07	G901203	12/2020

Lupin is notifying these wholesalers, distributors, and mail order pharmacies by phone and through recall notification and is arranging for the return of all the recalled product. The manufacturer is advising patients taking recalled product to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the US Food & Drug Administration (FDA), it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their healthcare professionals. Please visit the agency’s website for more information.

Wholesalers, distributors, and retailers that have metformin ER 500 mg tablets which are being recalled should discontinue distribution of the recalled product lot immediately and return it to Inmar Rx Solutions, 635 Vine St., Winston Salem, NC 27101, phone (855) 532-1856.

Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (855) 532-1856 Monday through Friday 9:00 AM to 5:00 PM EST. For reimbursement, please have the recalled lot returned to Inmar Rx Solutions; the lot number can be found on the side of the bottle.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report online
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the US Food and Drug Administration.

Company Contact Information

Consumers: Inmar Rx Solutions, Inc.

(855) 532-1856

Media: Arvind Bothrar

+91-22-66402137
arvindbothra@lupin.com

Product Photos

For product photos, please refer to the FDA Link.

About this recall:
Amneal was notified by the U.S. FDA that the Agency’s testing of seven lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, showed N-Nitrosodimethylamine (NDMA) amounts above acceptable FDA levels. FDA recommended the recall of the seven tested lots. Amneal has agreed to this recall and has further decided to extend the recall to all lots within expiry of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, out of an abundance of caution. Further scientific evaluations are ongoing at Amneal.

To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall.

Amneal’s Metformin Hydrochloride Immediate Release Tablets, USP are not affected by this recall.

Metformin HCl Extended Release Tablets, USP, 500 mg and 750 mg, manufactured by Amneal, are prescription, solid oral products that are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

The Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, subject to the recall, are identified by the NDC numbers stated on the product label.

Metformin HCl Extended Release Tablets, USP, 500 mg)

NDC Number	Bottle Count
53746-178-01	100 count bottles
53746-178-05	500 count bottles
53746-178-10	1000 count bottles
53746-178-90	90 count bottles
53746-178-Bulk	Bulk
65162-178-09	90 count bottles
65162-178-10	100 count bottles
65162-178-11	1000 count bottles
65162-178-50	500 count bottles

Metformin HCl Extended Release Tablets, USP, 750 mg

NDC Number	Bottle Count
53746-179-01	1,000 count bottles
53746-179-Bulk	Bulk Box
65162-179-10	100 count bottles

The affected Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, lots were distributed nationwide in the US directly to Wholesalers, Distributors, Retailers and Repackagers.

Amneal is notifying its direct customers via mail (UPS Standard Overnight) by mailing a recall notification letter and is arranging for return of all the recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.

Customers who purchased the impacted product directly from Amneal may call Amneal at 1-833-582-0812 or email to AmnealproductrecallDS@amneal.com, Monday – Friday, 8:00 am – 5:00 pm, EST, for further information.

Retailers who have Metformin Hydrochloride Extended Release Tablets, USP, 500 mg or 750 mg, which are being recalled, should cease dispensing and contact Inmar at 855-532-1851 or via email at Rxcalls@inmar.com Monday – Friday, 8:00 am – 5:00 pm, EST, to arrange for product return.

If you would like to report any adverse reactions or quality problems experienced with the use of this product you may contact Amneal Drug Safety by phone at 1-877-835-5472, Monday – Friday, 8:00 am – 6:00 pm, EST, or via e-mail at DrugSafety@amneal.com.

Any adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report online
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company Contact Information

Consumers:

Amneal

1-833-582-0812

AmnealproductrecallDS@amneal.com

Media:

Candis Edwards

Information@amneal.com

Product Photos

For product photos please refer to the FDA Link

About this Recall:

Apotex is voluntarily recalling all lots of Metformin Hydrochloride (HCl) ER Tablets, 500 mg within expiration to the retail level. The United States (US) Food and Drug Administration (FDA) tested 1 lot of Apotex’s metformin HCl ER tablets, and found that tablets contain levels of the N-Nitrosodimethylamine (NDMA) impurity greater than the acceptable daily intake limit. As a result, the FDA recommended recall of the 1 tested lot. Apotex is recalling this lot, and out of an abundance of caution, the company has extended the recall to include all lots of Apotex’s metformin ER tablets in the US. Selling of this product was stopped in the US in February 2019 and only limited product remains on the market. To date, there have not been any reports of adverse events related to use of this product.

What this means to you:

Consumers with questions regarding this recall can contact Apotex by phone at 1-800-706-5575 (8:30 AM – 5:00 PM, EST Monday through Friday) oremail UScustomerservice@Apotex.com. Consumers should contact their physician or health-care provider if they have experienced any problems that may be related to taking or using this drug product.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

Apotex Corp. is voluntarily recalling all lots of Metformin Hydrochloride (HCl) ER Tablets, USP 500 mg within expiration to the retail level. The United States (US) Food and Drug Administration (FDA) tested 1 lot of Apotex’s metformin HCl ER tablets, and it was found to contain levels of the N-Nitrosodimethylamine (NDMA) impurity greater than the acceptable daily intake limit. As a result, the FDA recommended recall of the 1 tested lot. Apotex is recalling this lot, and out of an abundance of caution, the company has extended the recall to include all lots of Apotex’s metformin HCl ER tablets in the US. Selling of this product was stopped in the US in February 2019 and only limited product remains on the market. To date, no reports of adverse events related to use of this product have been received.

Risk Statement: NDMA is classified as a substance that could cause cancer based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods (such as meats, dairy products, and vegetables). The FDA has stated patients should continue taking metformin tablets, even after recalls occur, until they speak with their health care provider who can prescribe a replacement.

Product	Strength	Pack Size	NDC Number
Metformin Hydrochloride Extended-Release Tablets, USP	500 mg	100's bottle	60505-0260-01

The impacted metformin ER tablets were distributed nationwide in the US to warehouse chains. Apotex is in the process of notifying its affected direct account wholesaler, distributor, chain distribution, and warehousing chains via mail (FedEx Standard Overnight) by mailing a recall notification letter and is arranging for return of all recalled product.

Wholesalers, distributors and retailers should return the recalled product to the place of purchase. Anyone with an existing inventory of the product should quarantine the recalled lots immediately. Customers who purchased the impacted product directly from Apotex can call Inmar Rx Solutions at 1-888-985-9014 (option 1) (9:00 AM – 5:00 PM, EST Monday through Friday), to arrange for their return.

2—0528-2020 Class 2 Metformin ER 500 mg – Apotex Corp, Voluntary Nationwide Recall Consumers with questions regarding this recall can contact Apotex by phone at 1-800-706-5575 (8:30 AM – 5:00 PM, EST Monday through Friday) or email UScustomerservice@Apotex.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report online
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the US Food and Drug Administration (FDA).

Company Contact Information

Consumers:

Apotex Corp.
1-800-706-5575
UScustomerservice@Apotex.com

Media:

Jordan Berman
1 (416) 749-9026 Ext. 7487
jberman@apotex.com

About this recall:
Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30 mg, 60 mg, and 90 mg NP Thyroid® (thyroid tablets, USP) to the consumer level. The products are being recalled because testing has found these lots to be superpotent. The product may have up to 115% of the labeled amount of Liothyronine (T3).

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive superpotent NP Thyroid, may experience signs and symptoms of hyperthyroidism (overactive thyroid) which include, but are not limited to, weight loss, heat intolerance, fatigue, muscle weakness, hypertension (high blood pressure), chest pain, rapid heart rate, or heart rhythm disturbances. Pregnant women who take superpotent NP Thyroid may also experience negative maternal and fetal outcomes including miscarriage and/or impairment of fetal development. The FDA is recommending patients talk to their healthcare professional before they stop taking their NP Thyroid medicine. To date, Acella has received 2 reports of adverse events known to be related to this recall.

NP Thyroid (thyroid tablets, USP) is composed of levothyroxine and liothyronine, and used to treat hypothyroidism (underactive thyroid). The products subject to recall are packed in 100-count bottles. Product images are provided below.

To best identify the product, the NDCs, product description, lot numbers, and expiration dates are listed. These lots were distributed nationwide in the United States (US) to Acella’s direct accounts.

Product	NDC Number	Lot Number (Expiration Date)
NP Thyroid 30 mg	42192-0329-01	M329A19-1 (20-Dec) M329H18-1 (20-July) M329J18-1 (20-Aug) M329J18-2 (20-Aug) M329J18-3 (20-Aug) M329M18-2 (20-Nov)
NP Thyroid 60 mg	42192-0330-01	M330J18-2A (20-Aug) M330J18-3 (20-Aug)
NP Thyroid 00 mg	42192-0331-01	M331G18-1 (20-Jun) M331J18-1 (20-Aug) M331J18-2 (20-Aug) M331M18-1 (20-Nov) M331M18-2 (20-Nov)

Acella is proactively notifying its wholesalers by email and phone to discontinue distribution of the product being recalled and is arranging for return of all recalled products. Patients who are currently taking NP Thyroid from the lots being recalled should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.

Consumers with questions about the recall can email Acella Pharmaceuticals at recall@acellapharma.com or contact Acella Customer Service at 1-800-541-4802, Monday through Thursday from 9:00 am to 5:00 pm ET and Friday from 9:00 am to 12:30 pm ET. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report online
Regular Mail or Fax: download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the US Food and Drug Administration (FDA).

Company Contact Information

Consumers:

Allen Fields, Senior Vice President, Clinical and Regulatory Affairs
1-800-541-4802

About this Recall:

Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30 mg, 60 mg, and 90 mg NP Thyroid® (thyroid tablets, USP) to the consumer level. The products are being recalled because our testing has found these lots to be superpotent. The product may have up to 115% of the labeled amount of liothyronine (T3).

What this means to you:

Patients being treated for hypothyroidism (underactive thyroid), who receive superpotent NP Thyroid, may experience signs and symptoms of hyperthyroidism (overactive thyroid) which include, but are not limited to, weight loss, heat intolerance, fatigue, muscle weakness, high blood pressure, chest pain, rapid heart rate, or heart rhythm disturbances. Pregnant women who take superpotent NP Thyroid may also experience negative maternal and fetal outcomes including miscarriage and/or impairment of fetal development. The FDA is recommending patients who are currently taking NP Thyroid from a lot being recalled should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription. View the FDA Recall Notification at the link below for a listing of lots being recalled.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

About this Recall:

Trividia Health, Inc. has announced a nationwide voluntary recall of one (1) True Metrix® Air Blood Glucose Meter distributed in the United States to AssuraMed. The one (1) impacted meter was packaged into a True Metrix Blood Glucose Meter Kit with the Lot number KW0135 and with UDI number (01)00021292006075(17) 200831(10)KW0135(21)TA1548753.

What this means to you:

The recalled meter has an incorrect factory-set unit of measure and displays blood glucose results in mmol/L rather than mg/dL. If this incorrect unit of measure is not noticed, the potential exists for the meter glucose result to be read as a lower blood glucose reading than expected. This can lead to the patient’s glucose level remaining high, which could result in serious injury or lead to life-threatening complications.

Consumers who have or may have the recalled True Metrix Air meter are instructed by the manufacturer to do the following:

Check to confirm if you have the impacted True Metrix Air meter by obtaining the meter serial number (TA1548753) from the serial number label located on the back of the meter, and the call Trividia Health toll-free at 1-800-518-5726, Monday to Friday, 8 AM to 8 PM EST.
If you have the impacted True Metrix Air meter, please stop using the meter and call Trividia Health immediately to verify the serial number, and to expedite return and replacement of the recalled True Metrix Air meter at no charge.
Consumers may continue to test blood glucose using any other Trividia Health blood glucose meter not included in this voluntary recall while waiting for their replacement meter to arrive. Use only the test strips that are intended for use with your blood glucose meter.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

About this recall:
Trividia Health, Inc. today announced it is initiating a nationwide voluntary recall of one (1) True Metrix® Air Blood Glucose Meter distributed in the United States to one customer (AssuraMed). The meter was not packaged into store-brand or retail branded packaging.

The company has determined that one (1) isolated True Metrix Air Blood Glucose Meter was packaged into a True Metrix Blood Glucose Meter kit and has an incorrect factory-set unit of measure; the meter displays glucose results in mmol/L rather than mg/dL. If a consumer does not notice the incorrect unit of measure, it is possible that the meter glucose result will be read as a lower blood glucose result than expected, and this may result in the patient’s glucose level remaining high, which can lead to serious injury or impairment with risk of death.

There is one (1) affected True Metrix Air meter with serial number TA1548753 that was packaged into a True Metrix Blood Glucose Meter Kit with the Lot number KW0135 and with UDI number (01)00021292006075(17)200831(10)KW0135(21)TA1548753. It has been determined that this kit was distributed nationwide in the United States (US) in February 2019. Trividia Health has not received any reports of patient injury or an adverse event related to this voluntary recall.

Consumers who have or may have the recalled True Metrix Air meter are instructed by the manufacturer to do the following:

Check to confirm if you have the affected True Metrix Air meter by obtaining the meter serial number ( TA1548753) from the serial number label located on the back of the meter, and then call Trividia Health toll-free at 1-800-518-5726, Monday – Friday, 8 AM – 8 PM EST.
If you have the affected True Metrix Air meter, please stop using the meter and call Trividia Health immediately to verify the serial number, and to expedite return and replacement of the affected True Metrix Air meter at no charge.

Consumers may continue to test blood glucose using any other Trividia Health blood glucose meter not included in this voluntary recall while waiting for their replacement meter to arrive. Use only the test strips that are intended for use with your blood glucose meter.

Notifications will be sent to US pharmacies, durable medical equipment providers and distributors who may have received this device from Trividia’s customer.

Patient safety is a top priority at Trividia Health. The company has notified the US Food and Drug Administration (FDA) of this voluntary product recall and is working with the customer who received the affected meter to quickly resolve this matter.

Users within the US may report adverse reactions or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online or by phone.

Complete and submit the report online
Regular Mail or Fax: download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the US FDA.

Company Contact Information

Consumers: Trividia Health

1-800-518-5726

Media: Annmarie Ramos, Sr. Manager, Product Marketing

800-342-7226, ext. 3190

About this Recall:

Avet Pharmaceuticals Inc. is initiating a voluntary recall of 8 lots of Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles to the consumer/user level. A list of impacted lots is available at the FDA Recall Notification website below.

What this means to you:

Consumers with questions regarding this recall should contact Qualanex at 1-888-424-4341 Monday – Friday, 8:00 am – 5:00 pm, EST or via email at recall@qualanex.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

Avet Pharmaceuticals Inc. (“Avet”), based in East Brunswick, New Jersey, is initiating a voluntary recall of the following lots of Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles listed in the table below to the consumer/user level.

Product	NDC Number	Lot Number	Expiration Date
Tetracycline HCl Capsules 250 mg, 100 count	23155-0017-01	H190666	JUL 2022
Tetracycline HCl Capsules 500 mg, 100	23155-0018-01	G190609	JUN 2022
Tetracycline HCl Capsules 500 mg, 100	23155-0018-01	G190610	JUN 2022
Tetracycline HCl Capsules 500 mg, 100	23155-0018-01	G190611	JUN 2022
Tetracycline HCl Capsules 500 mg, 100	23155-0018-01	L191027	NOV 2022
Tetracycline HCl Capsules 500 mg, 100	23155-0018-01	L191028	NOV 2022
Tetracycline HCl Capsules 500 mg, 100	23155-0018-01	K190953	OCT 2022
Tetracycline HCl Capsules 500 mg, 100	23155-0018-01	K190952	OCT 2022

These drug products are manufactured by Avet Pharmaceuticals and distributed under the Heritage Pharmaceuticals label. The voluntary recall is being initiated due to low out of specification dissolution test results.

2—0415-2020 Class 1 Tetracycline HCl Capsules – Avet Pharmaceuticals Voluntary Nationwide Recall the body to fight the infection, this could result in rapid progression of the infection and death. To date, Avet has not received adverse event reports or complaints related to this event.

Tetracycline HCl Capsules USP, 250 mg and 500 mg are indicated in the treatment of infections caused by susceptible strains of the designated organisms, including upper and lower respiratory infections, skin and soft tissues infections, infections caused by Rickettsiae, and as an adjunctive therapy in severe acne. The recalled Tetracycline HCl Capsules 250 mg and 500 mg lots were distributed to wholesalers and distributors nationwide in the US between August 2019 and March 2020.

Avet is notifying its distributors and customers and is arranging for the return of all recalled products. Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking this drug product. Pharmacies and healthcare facilities that have the drug product subject to this recall should immediately stop dispensing this drug product.

Consumers with questions regarding this recall should contact Qualanex at 1-888-424-4341, Monday – Friday, 8:00 am – 5:00 pm, EST or via email at recall@qualanex.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report online
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the US Food and Drug Administration.

Company Contact Information

Consumers: Avet Pharmaceuticals Inc.

1-888-424-4341
recall@qualanex.com

About this Recall:

What this means to you:

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

About this recall:
Avet Pharmaceuticals Inc. (“Avet”), based in East Brunswick, New Jersey, is initiating a voluntary recall of the following lots of Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles listed in the table below to the consumer/user level.

Product	NDC Number	Lot Number	Expiration Date
Tetracycline HCl Capsules 250 mg, 100 count	23155-0017-01	H190666	JUL 2022
Tetracycline HCl Capsules 500 mg, 100 count	23155-0018-01	G190609	JUN 2022
Tetracycline HCl Capsules 500 mg, 100 count	23155-0018-01	G190610	JUN 2022
Tetracycline HCl Capsules 500 mg, 100 count	23155-0018-01	G190611	JUN 2022
Tetracycline HCl Capsules 500 mg, 100 count	23155-0018-01	L191027	NOV 2022
Tetracycline HCl Capsules 500 mg, 100 count	23155-0018-01	L191028	NOV 2022
Tetracycline HCl Capsules 500 mg, 100 count	23155-0018-01	K190953	OCT 2022
Tetracycline HCl Capsules 500 mg, 100 count	23155-0018-01	K190952	OCT 2022

Low dissolution results in less tetracycline available in the body to fight infection. This can lead to treatment failures. For patients with compromised immune systems and the elderly, who may be taking tetracycline to treat a serious infection such as pneumonia, there is a reasonable probability that if there is not enough tetracycline in the body to fight the infection, this could result in rapid progression of the infection and death. To date, Avet has not received adverse event reports or complaints related to this event.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the US Food and Drug Administration.

Company Contact Information

Consumers: Avet Pharmaceuticals Inc.

1-888-424-4341
recall@qualanex.com

About this Recall:

Amneal Pharmaceuticals, LLC, Bridgewater, New Jersey is voluntarily recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL), packaged in 480 mL bottles to the Consumer Level. Nizatidine Oral Solution was distributed by Gemini Laboratories, LLC, a wholly owned subsidiary of Amneal Pharmaceuticals. The three recalled lots are identified in the FDA Recall Notification link below. Nizatidine Oral Solution is being recalled due to potential N-Nitrosodimethylamine (NDMA) amounts exceeding the levels established by the FDA.

What this means to you:

Customers who purchased the impacted product directly from Amneal can call Inmar at (855) 319-4807, Monday – Friday, 8:00 am – 6:00 pm, EST, or e-mail at DrugSafety@amneal.com for further information. Consumers should contact their physician or other healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Consumers who have Nizatidine Oral Solution which is being recalled should stop using the product and can call Inmar at 855-319-4807, Monday – Friday, 8:00 am – 5:00 pm, EST for further information.

Consumers who would like to report adverse reactions or quality problems experienced with the use of this product can contact Amneal Drug Safety by phone at 1-877-835-5472, Monday thru Friday, 8:00 am – 6:00 pm, EST, or e-mail at DrugSafety@amneal.com.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

About this recall:
Amneal Pharmaceuticals, LLC, Bridgewater, New Jersey is voluntarily recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL), packaged in 480 mL bottles to the Consumer Level. Nizatidine Oral Solution was distributed by Gemini Laboratories, LLC, a wholly owned subsidiary of Amneal Pharmaceuticals. The three recalled lots are identified in the table below. Nizatidine Oral Solution is being recalled due to potential N-Nitrosodimethylamine (NDMA) amounts exceeding the levels established by the FDA.

Amneal Pharmaceuticals, LLC has not received any reports of adverse events that have been confirmed to be directly related to this recall. Nizatidine Oral Solution manufactured by Amneal, is a prescription oral product used for the short-term treatment and maintenance therapy of ulcers and for the treatment of esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD).

The Nizatidine Oral Solution lots subject to the recall can be identified by the NDC number and lot number listed on the product label:

NDC Number	Description	Lot Number	Expiration Date
60846-0301-15	Nizatidine Oral Solution	06598004A	04/2020
60846-0301-15	Nizatidine Oral Solution	06599001A	12/2020
60846-0301-15	Nizatidine Oral Solution	06599002A	12/2020

The affected Nizatidine Oral Solution lots were distributed directly to wholesalers who further distributed to retail pharmacies and consumers nationwide in the USA.

Amneal is notifying its direct customers by mailing (FED Ex Standard Overnight) a recall notification letter and is arranging for return of all recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report online
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Link to FDA website.

Company Contact Information

Consumers: Inmar

855-319-4807
DrugSafety@amneal.com

Media: Ms. Candis Edwards

Information@amneal.com

About this Withdrawal:

The U.S. Food and Drug Administration (FDA) today announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as NNitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac).

What this means to you:

Patients and consumers should contact their physician or health care provider with any questions related to this withdrawal and/or if they have experienced any problems that may be related to taking Ranitidine Products. The FDA recommends consumers stop taking OTC ranitidine drugs and consider other approved OTC products if they wish to continue treating their condition. The FDA also recommends if you have had a prescription for this drug, to talk with your doctor or pharmacist before stopping this drug. Because of the current COVID-19 pandemic, the FDA recommends consumers not take their drugs to a drug take-back location but follow the specific disposal directions in the medication guide or package insert or follow the FDA’s recommended steps, which include ways to safely dispose of these drugs at home.

For more information regarding this FDA Withdrawal Notification, please refer to the FDA website.

Complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

About this recall:
The U.S. Food and Drug Administration today announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.

“The FDA is committed to ensuring that the medicines Americans take are safe and effective. We make every effort to investigate potential health risks and provide our recommendations to the public based on the best available science. We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.”

NDMA is a probable human carcinogen (a substance that could cause cancer). In the summer of 2019, the FDA became aware of independent laboratory testing that found NDMA in ranitidine. Low levels of NDMA are commonly ingested in the diet, for example NDMA is present in foods and in water. These low levels would not be expected to lead to an increase in the risk of cancer. However, sustained higher levels of exposure may increase the risk of cancer in humans. The FDA conducted thorough laboratory tests and found NDMA in ranitidine at low levels. At the time, the agency did not have enough scientific evidence to recommend whether individuals should continue or stop taking ranitidine medicines, and continued its investigation and warned the public in September 2019 of the potential risks and to consider alternative OTC and prescription treatments.

New FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers. The testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.

With today’s announcement, the FDA is sending letters to all manufacturers of ranitidine requesting they withdraw their products from the market. The FDA is also advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more; for those who wish to continue treating their condition, they should consider using other approved OTC products. Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA. To date, the FDA’s testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).

In light of the current COVID-19 pandemic, the FDA recommends patients and consumers not take their medicines to a drug take-back location but follow the specific disposal instructions in the medication guide or package insert or follow the agency’s recommended steps, which include ways to safely dispose of these medications at home.

The FDA continues its ongoing review, surveillance, compliance and pharmaceutical quality efforts across every product area, and will continue to work with drug manufacturers to ensure safe, effective and high-quality drugs for the American public. The FDA encourages health care professionals and patients to report adverse reactions or quality problems with any human drugs to the agency’s MedWatch Adverse Event Reporting program:

Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
Download and complete the form, then submit it via fax at 1-800-FDA-0178.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Inquiries Media: Consumer: Sarah Peddicord

888-INFO-FDA
301-796-2805

Related Information

Link to full FDA Alert: FDA Alert Ranitidine HCL Full Market Withdrawal.

About this Recall:

Hikma Pharmaceuticals is voluntarily extending its prior recall of certain lots of Ketorolac Tromethamine Injection USP 30mg/mL. The drug is being recalled because small black pieces, were seen in some of the recalled lots.

What this means to you:

Patients and consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using Ketorolac Tromethamine Injection, 30mg/mL.

For more information regarding FDA Recall Notifications, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

About this recall:
Hikma Pharmaceuticals PLC (Hikma, Group), today announces that its subsidiary Hikma Pharmaceuticals USA Inc. (formerly known as West-Ward Pharmaceuticals Corp.; “Hikma”) is voluntarily extending its previously-announced recall of certain lots (listed below) of Ketorolac Tromethamine Injection USP 30mg/mL, 1mL fill/2mL vials to the medical facility and retail levels.

The product is being recalled due to the presence of small visible particulate matters of a gelatinous/oily nature that appear black in some of the recalled lots. On December 23, 2019, Hikma voluntarily initiated a recall of this product to the direct customer level.

In coordination with the U.S. Food and Drug Administration (FDA), Hikma is extending the recall to the medical facility and retail levels. Administration of the affected product could potentially result in the deposition of particulates in the lungs of patients, which could result in multiple pulmonary microemboli with subsequent acute respiratory distress for patients receiving the drug intravenously.

Although Hikma has not received any reports of adverse events related to this issue, it is nonetheless extending its recall of these products out of an abundance of caution and to promote patient safety, which is Hikma’s highest priority.

The lots being recalled were manufactured between March 22, 2018, and February 21, 2019. Hikma investigated the cause of the problem and decided to suspend manufacturing of this product until an appropriate solution can be implemented to prevent recurrence.

Ketorolac Tromethamine Injection is a nonsteroidal anti-inflammatory drug (“NSAID”) that is indicated for the shortterm (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level.

The affected lot numbers and expiration dates being recalled are as follows:

NDC Number	Product Name and Strenth	Size	Lot Number	Expiration Date
0641-6042-25	Ketorolac Tromethamine Injection 30mg/mL	1mL Fill/2mL Vial	038366	Mar 2020
0641-6042-25	Ketorolac Tromethamine Injection 30mg/mL	1mL Fill/2mL Vial	048365	Apr 2020
0641-6042-25	Ketorolac Tromethamine Injection 30mg/mL	1mL Fill/2mL Vial	048367	Apr 2020
0641-6042-25	Ketorolac Tromethamine Injection 30mg/mL	1mL Fill/2mL Vial	078301	Jul 2020
0641-6042-25	Ketorolac Tromethamine Injection 30mg/mL	1mL Fill/2mL Vial	078303	Jul 2020
0641-6042-25	Ketorolac Tromethamine Injection 30mg/mL	1mL Fill/2mL Vial	118358	Nov 2020
0641-6042-25	Ketorolac Tromethamine Injection 30mg/mL	1mL Fill/2mL Vial	019413	Jan 2021
0641-6042-25	Ketorolac Tromethamine Injection 30mg/mL	1mL Fill/2mL Vial	029353	Feb 2021

The product can be identified by name and NDC and lot codes, which are clearly stated on the product label, along with Hikma Pharmaceuticals USA Inc./West-Ward Pharmaceutical Corp.’s name and address. Images of the vial and shelf pack labels are included below:

The product was distributed to Hikma’s direct customers nationwide. Hikma notified its direct customers as part of the initial recall, asking them to contact medical and retail level facilities to locate and remove the recalled product from distribution channels and return the recalled lots to Hikma. Hikma is now asking customers at the medical and retail level facilities to locate and remove the recalled product from their channels and return the recalled lots to Hikma.

For recall inquiries, please contact Hikma using the information provided below:

Hikma Contact:
Hikma Pharmaceuticals USA Inc. - Customer Service
(P): (800) 631-2174
usrecall@hikma.com
(F): (732) 542-0940
Hours: Monday-Friday 8am-7pm EST

Qualanex LLC (Hikma 3rd Party Recall Service Provider)
Qualanex LLC
1410 Harris Road
Libertyville, IL 60048-2435
(E): recall@qualanex.com

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report online
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Link to FDA website.

Refer to the United States Food & Drug Administration (FDA) for further information on recalls.
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Drug Recalls

About this recall:

What this means to you:

Table 1. Accupril^®(Quinapril HCl Tablets), 10 mg, 20 mg, and 40 mg

Annual Wholesaler Acquisition Cost (WAC)

Table 1. Six recalled Accuretic (quinapril HCl/hydrochlorothiazide) lots in 90-count bottles

Table 2. Five recalled quinapril HCl/HCTZ lots in 90-count bottles

Table 1. Recalled Lots of Orphenadrine Citrate ER Tablets

Metformin HCl ER Tablets, USP 750 mg

Nitroglycerin Lingual Spray

Company Contact Information

DDAVP® Nasal Spray 10 mcg/0.1 mL, 5mL

Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5 mL

Stimate® Nasal Spray 1.5 mg/mL, 2.5 mL

Metformin HCl ER Tablets USP, 750 mg

Metformin HCl Extended Release Tablets, USP, 500 mg)

Metformin HCl Extended Release Tablets, USP, 750 mg

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Careers

Drug Recalls - Prime Therapeutics

About us

Corporate social responsibility

Solutions overview

Modern technology

Drug access

Clinical solutions

Condition management

Specialty drug management

Government solutions

Single-state programs

Read

Watch

Listen

Home Delivery

Specialty Pharmacy

Navigate to

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Drug Recalls

About this recall:

What this means to you:

Table 1. Accupril®(Quinapril HCl Tablets), 10 mg, 20 mg, and 40 mg

Annual Wholesaler Acquisition Cost (WAC)

Table 1. Six recalled Accuretic (quinapril HCl/hydrochlorothiazide) lots in 90-count bottles

Table 2. Five recalled quinapril HCl/HCTZ lots in 90-count bottles

Table 1. Recalled Lots of Orphenadrine Citrate ER Tablets

Metformin HCl ER Tablets, USP 750 mg

Nitroglycerin Lingual Spray

Company Contact Information

DDAVP® Nasal Spray 10 mcg/0.1 mL, 5mL

Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5 mL

Stimate® Nasal Spray 1.5 mg/mL, 2.5 mL

Metformin HCl ER Tablets USP, 750 mg

Metformin HCl Extended Release Tablets, USP, 500 mg)

Metformin HCl Extended Release Tablets, USP, 750 mg

Login Portals

Compliance / Legal

Careers

Table 1. Accupril^®(Quinapril HCl Tablets), 10 mg, 20 mg, and 40 mg