Glenmark, Sun Pharma, Zydus recall medicines in US over manufacturing issues

According to recent information collected from the U.S. Food and Drug Administration (FDA), major leading pharmaceutical firms in India, Glenmark Pharmaceuticals, Sun Pharmaceutical Industries, and Zydus, are recalling multiple drug products in the U.S. market due to manufacturing-related problems.

The Mumbai-based Glenmark Pharmaceuticals has initiated a Class II recall for over 25 drug products which had discrepancies against the current good manufacturing practices (CGMP); the recall started on March 13 from its U.S. subsidiary, Glenmark Pharmaceuticals Inc. (New Jersey).

These include Propafenone Hydrochloride ER capsules (for the irregular heartbeat), Solifenacin Succinate Tablets (for overactive bladder), Voriconazole Tablets (an antifungal drug), as well as neurotherapeutic medications like Lacosamide, Frovatriptan Succinate, and Rufinamide Tablets. Class II recalls involve products that pose a remote probability of causing temporary or medically reversible damage to health and low risk for serious consequences.

Sun Pharmaceutical Industries Inc., a U.S. division of Sun Pharma, has pulled from its shelves 13,728 bottles of Gabapentin capsules over possible cross-contamination. Gabapentin is for seizures and nerve pains. The recall was pledged on March 4 and falls under the Class III category that includes products that are less likely to be adverse effect in health.

Zydus Pharmaceuticals (USA) Inc. is recalling around 3,144 bottles of Chlorpromazine Hydrochloride Tablets, mainly among consumers, mostly patients suffering from psychiatric disorders like schizophrenia and bipolar disorder. This notice of recall came on April 3 due to an impurity of N-Nitroso-Desmethyl Chlorpromazine above the permissible limits.

Such recalls now serve as a strong reminder of a very strong will and commitment of the FDA to the highest quality and lifesaving patient safety standards in the United States.