Nostrum Laboratories recalls metformin tablets over safety concerns

pharmafile | November 4, 2020 | News story | Manufacturing and Production, Research and Development Nostrum laboratories, metformin, recall 

Missouri-based Nostrum Laboratories has issued a product recall of its type 2 diabetes drug metformin to the FDA over concerns it could contain cancer-causing chemicals, it has emerged.

The recall of the USP 750 mg dosage metformin HCl extended release tablets was announced after an evaluation identified unacceptable levels of Nitrosamine and N-Nitrosodimethylamine (NDMA), a possible carcinogen which is used to make rocket fuel, according to the US Environmental Protection Agency.  

The company advised users of the drug in an announcement to the FDA: “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. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.”

Nostrum has reached out to distributors to facilitate the swift return of the offending products. Despite initiating the recall, the company said it had not been made aware of any adverse events related to the drug.

Matt Fellows

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