DRUG INFORMATION HIGHLIGHTS

• In October 2023, the FDA instructed consumers to stop use of more than 20 over-the-counter (OTC) eye drop products due to the risk for eye infections that could lead to partial vision loss or blindness. Subsequently, Harvard Drug Group issued a voluntary recall to the consumer level for all lots of certain Rugby® brand ophthalmic drugs supplied by Velocity. Cardinal Health also issued a voluntary recall to the consumer level for all lots of certain Leader™ brand ophthalmic drops supplied by Velocity. In addition, Kilitch Healthcare India Limited voluntarily recalled all lots within expiry of certain ophthalmic products to the consumer level. These ophthalmic products are being recalled due to potential safety concerns after FDA investigators found unsanitary manufacturing conditions.
• Bayer has voluntarily recalled 1 lot of larotrectinib (Vitrakvi®) oral solution 20 mg/mL in 100 mL glass bottles to the consumer/user level due to microbial contamination (Penicillium brevicompactum) found during stability testing.
• Novartis has recalled 2 lots of cyclosporine (Sandimmune®) oral solution in the strength of 100 mg/mL to the consumer level due to crystal formation observed in some bottles; this could potentially result in incorrect dosing. The issue was found during an investigation of crystallization in a different lot.
• Insight voluntarily recalled 2 lots of Ting® 2% Miconazole Nitrate Athlete’s Foot Antifungal Spray Powder to the consumer level following detection of the presence of benzene. Benzene is not an ingredient in this OTC product and is considered a human carcinogen.
• KinderFarms recalled all lots of KinderMed™ Infants’ Pain & Fever oral suspension (acetaminophen – 160 mg/5 mL) and KinderMed Kids’ Pain & Fever oral suspension (acetaminophen – 160 mg/5 mL) to the retail and consumer level. These OTC products were recalled due to acetaminophen instability as sample batches showed that some lots were not within range and thereby may lead to a health risk.
• InvaGen has voluntarily recalled 1 lot of vigabatrin for oral solution, USP 500 mg, to the consumer level due to seal integrity issues that allowed for powder leakage from the foil pouch. Leakage of powder containing the active ingredient could result in lower vigabatrin levels inside the pouch, leading to potential underdosing of the anticonvulsant.
• The FDA has announced that Novo Nordisk will discontinue manufacture of Levemir® 100 unit/mL FlexPen® and vials. Discontinuation of Levemir FlexPen will occur on April 1, 2024; however, supply disruptions are expected, starting in mid-January 2024. Vials will be available until the end of 2024. Full brand discontinuation will occur on December 31, 2024.

DRUG INFORMATION HAPPENINGS

• The FDA has published a communication instructing wholesalers, pharmacies, HCPs, and patients to check their product supply for counterfeit semaglutide (Ozempic®) 1 mg injection following seizure of counterfeit product from the U.S. drug supply chain.  
• Novo Nordisk is taking action to protect patients/consumers from adulterated and misbranded injectable compounded products claiming to contain semaglutide.  
• The American Academy of Dermatology (AAD) published updated guidelines on the use of phototherapy and systemic therapies for adults with atopic dermatitis.
• The American Society of Clinical Oncology (ASCO) published clinical guidance on alternative treatments due to drug shortages in oncology.

CDC PULSE POINTS

• The CDC has released recommendations on the 2024 immunization schedule for adults (≥ 19 years of age) and children/adolescents (≤ 18 years of age).
• More than 77,000 additional doses of nirsevimab-alip (Beyfortus™) 100 mg have been released and will be distributed through the Vaccines for Children Program and commercial pathways. The long-acting monoclonal antibody is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in (1) neonates and infants born during or entering their first RSV season and (2) children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
• The CDC has announced that it will expand testing of international air traveler samples through its Traveler-based Genomic Surveillance (TGS) program to test for influenza, RSV, SARS-CoV-2, and other select respiratory viruses.