Glenmark, Granules, Zydus Recall Drugs in US: USFDA Alert

According to the US Food and Drug Administration (USFDA), products of Glenmark, Granules India, Sun Pharma, Zydus, and Unichem have been voluntarily recalled in the United States due to manufacturing deficiencies.

Due to the complaints of gritty texture and CGMP deviations, Glenmark Pharmaceuticals' US subsidiary is recalling 13,824 tubes of Azelaic Acid Gel produced at its Goa plant. The Class II recall, which was announced on September 17, is valid for the entire country and may indicate potential health consequences of temporary or medically reversible nature.

Granules India is recalling more than 49,000 extended-release capsules of Dextroamphetamine and Amphetamine variants because the impurity and degradation specifications have not been met. The Class III recall, which was given on August 28, creates the possibility of minor or no adverse health effects.

Sun Pharma's US branch is a product of unsuccessful dissolution tests, so a withdrawal of 1,870 kits of a renal imaging agent is carried out in the frame of a Class II recall made on September 3. In the same way, Zydus Pharmaceuticals (USA) Inc. removed 8,784 bottles of Entecavir tablets on September 4 due to treatment and release of degradation of the active principle.

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Despite this, India is still the country with the highest number of USFDA-approved pharmaceutical plants located outside the US, which greatly emphasizes its importance in the global supply chain of the pharma industry. The recalls are a reminder of the difficulties that are still present in the strict enforcement of manufacturing and quality standards in overseas markets.