STATES: Nationwide, to wholesalers, distributors, and mail-order pharmacies.
RECALL: Metformin Hydrochloride Extended-Release Tablets USP (generic equivalent of Fortamet®), 500mg, lot G901203 - Probable Carcinogen.
Lot exceeded the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA). Made by Lupin Pharmaceuticals Inc.
To date, Lupin Pharmaceuticals Inc. has not received any reports of adverse events related to this recall.
Metformin Hydrochloride Extended-Release Tablets USP, 500mg is a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. It is packaged in a bottle containing 60 tablets with NDC 68180-336-07. The product can be identified by the NDC and the lot number available on the side of the bottle label. The affected lot of Metformin Hydrochloride Extended-Release Tablets USP, 500mg is included in below table:
Product Name: Metformin Hydrochloride Extended-Release Tablets USP, 500mg
Lot Number: G901203
Expiration Date: 12/2020
Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.
ACTION: Patients taking Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the U.S. Food & Drug Administration, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.
CONTACT: Inmar Rx Solutions, Inc. at (855) 532-1856 Monday – Friday 09:00 am to 05:00 pm EST. For reimbursement, please have the recalled lot returned to Inmar Rx Solutions, Inc.; the lot number can be found on the side of the bottle.
Lupin Pharmaceuticals Inc. is notifying its wholesalers, distributors, and mail order pharmacies by phone and through recall notification and is arranging for the return of all the recalled product lot. Please visit the agency’s website for more information at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin.