Sun Pharma, Lupin, and Alkem Labs Recall Products from US Market, USFDA Issues Class II Recalls

19 Mar 2024 , 10:33 AM

Sun Pharma, Lupin Laboratories, and Alkem Laboratories are recalling pharmaceutical products from the US market, as reported by the US Food and Drug Administration (USFDA).

Sun Pharma, based in Mumbai, is recalling 54,960 bottles of Mesalamine Extended-Release Capsules used to treat ulcerative colitis due to ‘Failed Dissolution Specifications.’ The product was manufactured at Sun Pharma’s Mohali unit.

The Mohali facility has been under USFDA scrutiny, and corrective actions were directed by the regulator. Recent quarterly updates indicate ongoing issues at the facility.

Ascend Laboratories, a subsidiary of Alkem Ltd., is recalling 71,244 units of Fosfomycin Tromethamine Granule sachets, an antibiotic for bladder infections, due to ‘failed Impurities/degradation specification.’ Alkem in India manufactured the product.

Lupin, based in Mumbai, is recalling an unspecified number of Voriconazole for Oral Suspension tablets in the US, used to treat fungal infections. Lupin Pharmaceuticals Inc, a unit of the company, is recalling the affected lot manufactured by Novel Laboratories, Inc., Somerset, USA, due to ‘incorrect or missing package Insert.’

All three recalls are categorized as Class II recalls by the USFDA, indicating the potential for temporary or medically reversible adverse health consequences.

Indian pharmaceutical companies play a significant role globally, supplying 20% of pharma generics, 60% of global vaccines, and 40% of medicines in the US, as per the Indian Pharmaceutical Association.

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