Glenmark, Sun Pharma recall drugs in the US over labelling and manufacturing concerns, confirms USFDA

Glenmark Pharma and Sun Pharmaceutical Industries, prominent players in the Indian pharmaceutical sector, are initiating product recalls in the US market due to labeling and manufacturing concerns, as reported by the US Food and Drug Administration (USFDA).

Glenmark Pharmaceuticals recalled 37,200 bottles of Indomethacin capsules. The drug is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate acute pain and relieve symptoms of arthritis (osteoarthritis and rheumatoid arthritis) or gout, such as inflammation, swelling, stiffness, and joint pain.

The report stated that the products were mislabeled as Naproxen (used for similar purposes). The recall was initiated on November 7, 2023. The products were manufactured at Glenmark’s plant in Goa. This was a Class II recall. Class II USDA recalls involve a potential health hazard situation in which there is a remote probability of adverse health consequences from eating the food.

Meanwhile, Sun Pharma recalled 2016 bottles of buPROPion Hydrochloride Extended-Release Tablets. This medication is used in the treatment of depression. The product was recalled due to “Failed Dissolution Specifications”, the US FDA report stated.