Heads up, consumers: A diabetes drug is facing recall because the medication contains excess levels of a cancer-causing agent, the U.S. Food and Drug Administration (FDA) announced this week.
Marksans Pharma Limited, a pharmaceutical company in India, announced an expanded recalled of its Metformin hydrochloride extended-release tablets, a drug used to help those who suffer from type 2 diabetes to lower their blood glucose levels. The recall, which was initially announced in June, was expanded on Monday to include an additional 76 unexpired lots of the medication.
“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,” the FDA said when announcing the recall.
NDMA is a “probable human carcinogen,” meaning it's a substance that can lead to cancer, per the FDA.
“NDMA is a known environmental contaminant found in water and foods, including meats, dairy products and vegetables. Marksans Pharma Limited has not received any reports of adverse events that have been related to this recall,” the FDA said.
The recall impacts metformin tablets between 500 mg and 750 mg. The tablets were sold under the brand name Time-Cap Labs, Inc., according to the announcement.
The following products have been called back:
Metformin Hydrochloride Extended-Release Tablets, USP 500mg:
90 counts: 49483-623-09
100 counts: 49483-623-01
500 counts: 49483-623-50
1000 counts: 49483-623-10
Metformin Hydrochloride Extended-Release Tablets, USP 750mg:
100 counts: 49483-624-01
The 500 mg tablets are debossed with “101” on one side and are plain on the other. The 750 mg tablets, meanwhile, are also debossed with “102” on one side and are plain on the other, per the FDA.
“Consumers taking these recalled product lots of Metformin ER Tablets should continue taking it until a doctor or pharmacist gives them a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their health care professional,” the FDA warned. The consumer “should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.”