Apotex Corp. Issues Voluntary Nationwide Recall of Metformin Hydrochoride Extended-Release Tablets 500 mg Due to Detection of N-nitrosodimethylamine (“NDMA”)
Kehoe Law Firm, P.C. is making consumers aware that on May 28, 2020, the FDA reported that Apotex Corp. announced that Apotex “. . . is voluntarily recalling all lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg within expiry to retail level. Apotex was notified by the U.S. Food and Drug Administration . . . that one lot of Metformin Hydrochloride Extended-Release Tablets, USP was tested and showed results for N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit . . . and recommended recall of the one tested lot. Apotex Corp has agreed to recall this lot, and out of an abundance of caution, the company is extending the recall to all lots of Metformin Hydrochloride Extended-Release Tablets in the US.” [Emphasis added.]
According to the recall announcement’s “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.” [Emphasis added.]
Drugtopics.com reported (“First Big Metformin Product Recalled, More on the Way”) that
[m]onths after FDA said it was investigating the carcinogenic ingredient NDMA in metformin products, the agency’s testing found elevated levels of NDMA in extended release (ER) metformin but not in the immediate release (IR) formulation, FDA said in a statement issued to Drug Topics®.
FDA is contacting 4 additional manufacturers with ER metformin above the acceptable level and “will continue to take quick and appropriate action when needed to protect American consumers,” the agency said. [Emphasis added.]
Purchasers of Metformin