KANSAS CITY, Mo. — Nostrum Laboratories has voluntarily recalled four lots of a popular Type 2 diabetes drug after determining it contained unacceptably high levels of a cancer-causing agent.
The Kansas City, Missouri-based company becomes the latest to recall its version of extended-release metformin since the issue was first detected by the U.S. Food and Drug Administration in May. Marksans Pharma Ltd. and Sun Pharmaceutical Industries Ltd., both based in India, joined at least eight other companies last month in issuing the voluntary recalls.
According to the U.S. Food and Drug Administration, testing of several lots of extended-release metformin revealed levels of N-Nitrosodimethylamine, known as NDMA, that exceeded the agency’s acceptable limits prompted the original May guidance.
The Miami Herald confirmed that the Nostrum recall applies specifically to:
• 100-tablet bottles of 750 mg Metformin Hydrochloride Extended Release Tablets, lot Nos. MET200101 and MET200301
• 500 mg Metformin Hydrochloride Extended Release Tablets, lot Nos. MET100201 and MET100401
All recalled bottles have an expiration date of May 2022, the Herald reported.
According to the FDA, NDMA is “classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”
The Nostrum medication was distributed nationwide to wholesalers in the form of off-white, oblong tablets marked with “NM7,” PennLive.com reported.
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