Recall report: Nostrum expands recall of diabetes drug metformin after carcinogen concerns
Generic metformin has been a thorn in drugmakers’ sides for months after a probable human carcinogen was found in tested lots. Now, one of the companies is expanding its recall to another lot of the drug.
Nostrum Laboratories out of Kansas City, MO voluntarily recalled one lot of metformin HCl extended release tablets, USP 750 mg, a type 2 diabetes drug (the generic equivalent to Glucophage tablets) after testing discovered elevated levels of nitrosamine, the probable carcinogen.
The recall is an expansion of a previous Nostrum recall in November for the same product and the same reasoning, the FDA said. The pills at issue from the November recall were a lower dosage of 500 mg.
Metformin is used to improve blood glucose control in adults with type 2 diabetes mellitus, and is an off-white, oblong tablet stamped with “NM7”. The lot in Monday’s recall is MET200501, with expiration dates of July 2022.
Nostrum has not been notified of any adverse effects from the now-recalled product, the FDA said. Anyone taking metformin who is concerned about the recalled batch is asked to consult with their physician before they stop taking the drug, as doing so could be dangerous.
The expanded recall is the latest in a line of at least eight manufacturers across the globe taking metformin off the shelves. In October, India’s Marksans Pharma pulled back an eye-popping 76 lots of its metformin version; in September, Sun Pharma recalled one lot of its Riomet ER, an extended-release version of the drug; in August, Bayshore Pharmaceuticals recalled one lot each of its 500- and 750-mg extended-release metformin; and in July, Lupin Pharmaceuticals pulled all lots of its extended-release metformin.
All recalls were linked to high nitrosamine levels found in the commonly used drug.