An Indian pharmaceutical company has expanded its voluntary recall of Metformin, a prescription drug used to control high blood sugar in patients with Type 2 diabetes.
The U.S. Food and Drug Administration posted the announcement on its website October 5.
Marksans Pharma Limited, India, is voluntarily expanding its earlier recall to include an additional 76 unexpired lots of Metformin Hydrochloride extended release tablets, USP 500mg and 750mg to the consumer level. Marksans “performed N-Nitrosodimethylamine (NDMA) testing of unexpired identified marketed lots and observed that NDMA content in some lots is exceeding the acceptable Daily Intake Limit (ADI) of 96ng/day, therefore, out of an abundance of caution, an additional 76 lots are being recalled.”
NDMA is a common contaminant found in water and foods, including cured and grilled meats, dairy products, and vegetables. Everyone is exposed to some level of NDMA, Janet Woodcock, director of the Center for Drug Evaluation and Research, has said.
Marksans Pharma Limited is notifying its distributors and customers by issuing notification letters and is arranging for return or replacement of recalled product lots. The full list of recalled lots can be found on the FDA website. The lot number of your medication is on the side panel of bottle labels, as well as shipper/case labels.
NDMA contamination was at the root of blood pressure and heart medication recalls in the past few years, and a Zantac recall last year.
