Lupin Gets USFDA Report as Glenmark, Torrent, Canada Recall Drugs; India Bans Pediatric Cough Syrups Over Safety

Lupin has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for its injectable drug manufacturing facility in Nagpur, India. The inspection took place from June 10 to 13, 2024, and the issuance of the EIR indicates the closure of the inspection process. Meanwhile, the FDA has recalled nearly 40 generic medications, including prescription and some over-the-counter drugs sold on platforms like Amazon and Walmart, due to manufacturing quality concerns. Among these recalls, Glenmark Pharmaceuticals has pulled two dozen generic medicines from the U.S.

market after its Indian manufacturing facility failed to meet FDA standards. Additionally, Torrent Pharmaceuticals' Captopril 25mg tablets have been recalled by Zimbabwe's Medicines Control Authority over quality issues. In Canada, Health Canada has recalled medications such as Life Brand Melatonin and Riva Acetaminophen due to dosage concerns. There is also an ongoing safety alert for a commonly taken blood pressure drug due to labeling errors that could lead to dangerous dosing. Separately, India has banned select pediatric cough syrups for children under four years old over safety concerns, advising parents and caregivers to switch to safer alternatives. These developments underscore heightened regulatory scrutiny on drug manufacturing quality and patient safety worldwide.