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Five pharma markers are recalling the diabetes medication due to the presence of a carcinogenic ingredient.
Five pharma makers are recalling their extended-release metformin tablets due to high levels of the carcinogenic ingredient N-nitrosodimethylamine (NDMA).
FDA said in a press release its testing found “certain extended release metformin products contain NDMA above the acceptable level.”
Soon after Apotex Corp and Amneal Pharmaceuticals recalled their metformin hydrochloride extended-release tablets, Teva Pharmaceuticals and Marksans Pharma Limited, India have issued recalls. The fifth manufacturer has not been named by the FDA.
Teva is recalling 14 lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, as well as 100 and 1000-count bottles.
Marksans Pharma is recalling Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, lot #XP9004.
Amneal is voluntarily recalling all lots of metformin hydrochloride extended-release tablets, USP, 500 mg and 750 mg, within expiry to the retail levels. The affected products were distributed nationwide in the US directly to wholesalers, distributors, retailers, and repackaers.
Apotex Corp is recalling all lots of metformin hydrochloride extended-release tablets, USP 500 mg, within expiry to retail level. However, Apotex stopped selling this product in the U.S. in February 2019, and there remains only a limited amount on the market, it said in a press release.