Sun Pharma, Lupin Laboratories, and Alkem Laboratories are recalling pharmaceutical products from the US market, as indicated in the US Food and Drug Administration’s (USFDA) weekly enforcement report.
Sun Pharmaceutical Industries, headquartered in Mumbai, is recalling 54,960 bottles of Mesalamine Extended-Release Capsules used to treat ulcerative colitis. The recall is due to failed dissolution specifications. The product was manufactured at Sun Pharma’s Mohali unit, which has been under US FDA scrutiny.
Ascend Laboratories, a subsidiary of Alkem Ltd., is recalling 71,244 units of Fosfomycin Tromethamine Granule sachets, an antibiotic for bladder infections, due to failed impurities/degradation specifications. This product was manufactured in India by Alkem.
Additionally, Mumbai-based Lupin is recalling Voriconazole for Oral Suspension tablets used to treat fungal infections. The recall is due to incorrect or missing package inserts. The affected lot was manufactured by Novel Laboratories, Inc., Somerset, USA.
All three recalls were classified as Class II recalls by the USFDA, indicating that the use or exposure to the product may cause temporary or medically reversible adverse health consequences. Despite attempts to reach out, responses from the companies regarding the matter remain pending.
Indian pharmaceutical companies play a significant role in global healthcare, supplying a substantial portion of the world’s pharmaceutical generics, vaccines, and medicines, including 40 percent of those in the US, as per the Indian Pharmaceutical Association.
