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:
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