Lupin Pharmaceuticals Inc., is recalling one lot of its generic version of the type 2 diabetes drug Fortamet, extended release metformin tablets, due to unsafe levels of a likely carcinogen known as NDMA, short for N-nitrosodimethylamine. The recall affects metformin hydrochloride extended release tablets USP, 500mg, with the NDC 68180-336-07, Lot# G901203, and expiration date 12/2020.
Lupin joins four other companies in recalls of extended-release tablets of metformin due to elevated levels of NDMA. Earlier this month, all versions of extended release metformin were recalled by Apotex Corp., 14 lots by Actavis, one lot by Marksans Pharma Limited, and all lots by Amneal Pharmaceuticals.
NDMA is a common environmental contaminant often found in food and water. The Food and Drug Administration (FDA) considers it safe to consume up to 96 nanograms of NDMA daily, but warned that sustained higher levels of consumption of the impurity may increase a person’s risk for cancer. Studies have found exposure to NDMA can cause tumors in laboratory mice.
Last fall, NDMA was found in several versions of the heartburn drug Zantac, and recalls of Zantac and generics containing ranitidine were initiated. On April 1, the FDA ordered the removal of all Zantac products from the market after finding that levels of NDMA in Zantac could increase to unsafe levels even under normal storage conditions.
The FDA said in a press announcement that it would continue to test for NDMA in metformin. Consumers with affected products should talk with their doctors if they have any questions or concerns.
Beasley Allen attorneys Frank Woodson and Lisa Courson are actively investigating potential claims involving regular Zantac/ranitidine use that may have led to cancer of the stomach, colon, intestines, kidneys, or pancreas. If you or a loved one may have been affected, please contact us. Beasley Allen is not currently taking claims related to metformin.