Granules Pharma Recalls Diabetes Drug Metformin HCI Extended-Release Tablets

Granules Pharmaceuticals, Inc. recalled twelve (12) lots of type 2 diabetes medication Metformin hydrochloride Extended-Release, in the form of oral film-coated tablets, for the potential presence of nitrosamine impurity, N-Nitrosodimethylamine (NDMA), above levels of the Acceptable Daily Intake Limit (ADI), the U.S. Food and Drug Administration or FDA said in a statement.

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