New Delhi — Leading Indian pharmaceutical companies Glenmark Pharmaceuticals, Sun Pharmaceutical Industries, and Zydus are recalling several drugs from the US market due to manufacturing-related lapses, as per the latest data released by the US Food and Drug Administration (FDA).
Mumbai-based Glenmark is recalling more than 25 drug products over deviations from current good manufacturing practices (CGMP). Its US subsidiary, Glenmark Pharmaceuticals Inc., headquartered in New Jersey, initiated the recall on March 13.
The Class II recall includes a range of medications such as Propafenone Hydrochloride extended-release capsules (used for irregular heartbeat), Solifenacin Succinate Tablets (used for overactive bladder), and antifungal Voriconazole Tablets. Other recalled drugs include Lacosamide, Frovatriptan Succinate, and Rufinamide Tablets, which are primarily used in managing neurological conditions.
According to the USFDA, a Class II recall is issued when a product may cause temporary or medically reversible health problems, with a remote likelihood of serious adverse consequences.
In a separate development, Sun Pharmaceutical Industries Inc., the US arm of Sun Pharma, has recalled 13,728 bottles of Gabapentin capsules due to the potential for cross-contamination. Gabapentin is commonly prescribed to treat seizures and nerve pain.
This recall, classified as Class III—deemed the least serious by the FDA—was initiated on March 4. Products under Class III recall are considered unlikely to cause adverse health effects.
Meanwhile, Zydus Pharmaceuticals (USA) Inc., a unit of Indian multinational Zydus, is recalling 3,144 bottles of Chlorpromazine Hydrochloride Tablets, used to treat psychiatric disorders such as schizophrenia and bipolar disorder.
The USFDA flagged the presence of an impurity, N-Nitroso-Desmethyl Chlorpromazine, found at levels exceeding the permissible limit. This Class II recall was initiated on April 3.
The USFDA maintains stringent oversight over pharmaceuticals sold in the country, mandating that manufacturers uphold high-quality standards to ensure patient safety. (Source: IANS)
