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Nostrum Laboratories is recalling Metformin HCl Extended Release Tablets because of NDMA above the acceptable daily intake limit.
Nostrum Laboratories (Kansas City, MO) announced on Nov. 2, 2020 that it was voluntarily recalling two lots of Metformin HCl Extended Release Tablets, USP 750 mg because of levels of nitrosamine (NDMA) impurities above the acceptable daily intake (ADI) limit. NDMA is classified as a probable human carcinogen.
The recalled lots (NDC 29033-056-01; lots MET200101 and MET200301) have an expiry date of 05/2022 and were distributed nationwide to wholesalers. The company is directing pharmacies to return the recalled product to the place of purchase.
Metformin HCl Extended Release Tablets, USP 750 mg are used to improve blood glucose control in adults with type 2 diabetes mellitus, according to the company. “Consumers should consult a healthcare professional to obtain a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their healthcare professional,” the company stated in a press release.
Adverse events associated with the recall may be reported to FDA through the agency’s MedWatch program.