Alembic Pharma, Lupin, others recall products in US market: USFDA report
New Delhi: Indian drug firms like Lupin, Marksans Pharma, Aurobindo Pharma and Alembic Pharmaceuticals are recalling products in the US market, as per the latest enforcement report by the US Food and Drug Administration (USFDA). While Lupin and Marksans Pharma are recalling diabetes drug, Aurobindo and Alembic are recalling psychiatric medication in the US market.
As per the latest enforcement report, the US based-arm of Lupin is recalling 6,540 bottles of Metformin Hydrochloride extended-release tablets USP, 500 mg, due to CGMP (Current Good Manufacturing Practice) deviations.
The drug has been manufactured at Lupin's Goa-based manufacturing plant.
Similarly, Marksans Pharma is recalling 11,279 bottles of the diabetes drug Metformin Hydrochloride extended-release tablets, which it had supplied to US-based Time-Cap Labs, Inc.
The US health regulator said it detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level in the product of both the companies.
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