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Lupin Pharmaceuticals Recalls One Lot of Metformin Hydrochloride Extended-Release Tablets

The product was found to more than the acceptable amount of NDMA, a carcinogen.

By: Contract Pharma

Contract Pharma Staff

Lupin Pharmaceuticals Inc. is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets USP (generic equivalent of Fortamet), 500mg, lot G901203 to the consumer level.   FDA analysis revealed that this lot exceeded the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen. To date, Lupin Pharmaceuticals Inc. has not received any reports of adverse events related to this recall.   Metformin Hydrochloride Exten...

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