BRIEF—Lupin voluntarily withdraws metformin product due to impurities

11 June 2020

Indian drugmaker Lupin’s US subsidiary is voluntarily recalling metformin hydrochloride extended-release tablets USP, a generic equivalent of Fortamet, 500mg, lot G901203 to the consumer level.

US Food and Drug Administration analysis revealed that this lot exceeded the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen based on results from laboratory tests.

To date, Lupin Pharmaceuticals Inc has not received any reports of adverse events related to this recall.

Metformin HCl is a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus.

On May 28, the FDA announced(www.fda.gov) that it had asked five pharmaceutical firms to voluntarily recall products containing extended-release formulations of metformin hydrochloride.

FDA officials said in a May 29 conference call that the firms that have been contacted are:

Actavis Pharma, which has withdrawn lots of metformin 500-mg tablets marketed,
Amneal Pharmaceuticals, which has voluntary withdrawn all lots of its metformin ER 500- and 750-mg tablets,
Apotex Corp, which said it had stopped selling that particular product in the USA in February 2019,
Lupin Pharma and
Marksans Pharma.