Lupin Pharmaceuticals, based in Mumbai, India, is recalling all lots of its metformin extended-release tablets after finding certain batches were above the acceptable daily intake level for N-Nitrosodimethylamine, NDMA, a carcinogen.
Metformin is the generic name for a type of drug that is used to improve blood glucose control in adults with Type 2 diabetes.
Granules Pharmaceuticals, based in Hyderabad, India, is recalling 12 lots of its metformin tablets for the same reason.
Neither drugmaker said they had received adverse event reports related to the recall.
The FDA said in late May that it had found unacceptable levels of NDMA in metformin. The impurity was originally found by online pharmacy Valisure in early March.
Five other drugmakers recalled their metformin products in June after the agency’s announcement.
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