Glenmark Pharma and Sun Pharma Initiate Product Recalls in the US Market: FDA Flags Labeling and Manufacturing Concerns

4 Dec 2023 , 12:37 PM

In a recent development, prominent players in the Indian pharmaceutical sector, Glenmark Pharma, and Sun Pharmaceutical Industries, find themselves in the spotlight as they initiate product recalls in the US market. The recalls, prompted by labeling and manufacturing concerns, have been reported by the US Food and Drug Administration (USFDA).

Glenmark Pharmaceuticals Recall:

Glenmark Pharmaceuticals has recalled 37,200 bottles of Indomethacin capsules, a nonsteroidal anti-inflammatory drug (NSAID) used for treating acute pain and symptoms of arthritis. The recall, initiated on November 7, 2023, was prompted by mislabeling issues. The products, manufactured at Glenmark’s Goa plant, were reportedly mislabeled as Naproxen, a drug used for similar purposes. The USFDA categorized this recall as a Class II recall, indicating a potential health hazard situation with a remote probability of adverse health consequences.

Sun Pharma Recall:

Meanwhile, Sun Pharmaceutical Industries recalled 2016 bottles of buPROPion Hydrochloride Extended-Release Tablets, a medication used in depression treatment. The recall, initiated on November 22, 2023, was attributed to ‘Failed Dissolution Specifications,’ according to the US FDA report. The drug in question was manufactured at Sun Pharma’s Halol plant. The USFDA classified this recall as a Class III recall, signifying a situation where consuming the drug will not cause adverse health consequences.

Market Impact:

In the stock market, shares of Sun Pharma were marginally down at Rs 1,225.00, while shares of Glenmark Pharmaceuticals were trading marginally down at Rs 785.00.