CONSUMER LEVEL RECALL NOTIFICATION OF METFORMIN
Effective 07/17/2020, Lupin Pharmaceuticals, Inc. is initiating a voluntary recall of all lots of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg, for NDC 68180-336-07, 68180-337-07, 68180-338-01 and 68180-339-09 shipped from Lupin Pharmaceuticals, Inc. to the consumer/user level. Analysis of certain tested batches revealed the presence of the impurity N-Nitrosodimethylamine (NDMA) above the acceptable daily intake level established by the FDA. Out of an abundance of caution, Lupin Pharmaceuticals, Inc. is recalling all lots within expiry.
Please click here for more details on the recalled lots.
This recall applies only to Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg, for NDC 68180-336-07, 68180-337-07, 68180-338-01 and 68180-339-09 shipped from Lupin Pharmaceuticals, Inc.