Drug Recalls: Glenmark and Biocon Withdraw Products in US Market

Glenmark and Biocon, two pharmaceutical companies, are recalling certain medications in the US due to manufacturing issues. The USFDA reports Glenmark is recalling Chlorpromazine for impurity issues, while Biocon is withdrawing a cholesterol drug due to failed specifications. Both recalls are classified as Class II by the USFDA.


Devdiscourse News Desk | New Delhi | Updated: 09-04-2025 18:06 IST | Created: 09-04-2025 18:06 IST
Drug Recalls: Glenmark and Biocon Withdraw Products in US Market
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Glenmark and Biocon, leading pharmaceutical companies, are facing scrutiny as they recall several products from the US market over manufacturing discrepancies, the US Food and Drug Administration (USFDA) reported.

The Mumbai-based drug firm Glenmark Pharmaceuticals' New Jersey unit is retracting 8,160 bottles of chlorpromazine hydrochloride tablets due to deviations from CGMP standards. These tablets exceeded recommended nitrosamine impurity levels, prompting a Class II recall initiated on March 11.

Meanwhile, Biocon Pharma Inc, another significant player, is recalling 2,184 bottles of cholesterol medication due to dissolution specification failures. This recall, also a Class II, began on March 17. Shares for both companies saw declines in the stock market, reflecting investor response to the recalls.

(With inputs from agencies.)

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