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The company is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, because of the detection of N-Nitrosodimethylamine.
Amneal Pharmaceuticals (Bridgewater, NJ) announced on May 29, 2020 that it is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, because of above FDA-acceptable amounts of N-Nitrosodimethylamine (NDMA) detected in the product. The recall was initiated after FDA notified the company that testing of seven lots of the product found above-acceptable NDMA impurity levels and recommended the product be recalled. The company has extended the recall to all lots within expiry “out of an abundance of caution.”
Metformin HCl Extended Release Tablets, USP, 500 mg and 750 mg are used as an adjunct to improve blood sugar control in adults with type 2 diabetes mellitus. NDMA is classified as a probable human carcinogen and is a known environmental contaminant.
The affected lots were distributed nationwide in the United States directly to wholesalers, distributors, retailers, and repackagers. The recall does not apply to the company’s Metformin Hydrochloride Immediate Release Tablets, USP.
The company has not received any reports of adverse events. Adverse events may be reported to FDA via the agency’s MedWatch program.