Lupin Pharmaceuticals, Inc. voluntarily recalled one lot of Metformin Hydrochloride Extended-Release Tablets (500-mg) after it tested positive for unsafe levels of a cancer-causing chemical impurity.
The recall involves Metformin ER (generic equivalent of Fortamet®) with Lot #G901203, NDC 68180-336-07 and Expiration Date 12/2020. It is packaged in a bottle containing 60 tablets.
Lupin Pharmaceuticals did not report any adverse events related to the recall.
FDA analysis revealed that this lot exceeded the acceptable daily intake limit for the impurity N-Nitrosodimethylamine (NDMA), a chemical that is classified as a probable human carcinogen.
The FDA is recommending that patients with diabetes should continue taking metformin even after recalls occur, until they talk to a healthcare professional who can prescribe a replacement.
“Patients with type 2 diabetes could face dangerous health risks if they stop taking their prescribed metformin,” according to the FDA.
Metformin ER recalls have also recently been issued by Actavis, Amneal Pharmaceuticals, Apotex Corp. and Marksans Pharma.
NDMA impurities may increase the risk of cancer if people are exposed to it at high levels over a long period of time.
In recent years, lawsuits have been filed by people who developed cancer after taking medications that were contaminated by NDMA, such as Zantac®.
Source: Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of One Lot of Metformin Hydrochloride Extended-Release Tablets USP, 500mg Due to the Detection of N-Nitrosodimethylamine (NDMA)