Indian drug firms like Lupin, Marksans 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.
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The US health regulator said it detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level in product of both the companies. NDMA has been defined as a probable human carcinogen.
Further, Aurobindo Pharma USA Inc, a unit of Hyderabad-based Aurobindo Pharma, is recalling 1,440 bottles of Clozapine tablets in the US market. The company is recalling the product, which is used to treat certain mood/mental disorders, across the US due to a consumer complaint of 50mg tablets being present in bottles of Clozapine 100mg.
Similarly, Alembic Pharmaceuticals is recalling 19,153 bottles of Aripiprazole tablets in the US for labelling mix up. The product is used in treatment of schizophrenia and bipolar disorder. All the ongoing voluntary recalls have been classified as class II recalls.
As per USFDA, a class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
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