Type 2 Diabetes Drug Recalled Due to Potential Contamination with Carcinogen

Earlier this week, a recall was issued for two lots of a popular type 2 diabetes drug, metformin, over concerns they may be contaminated with nitrosamine, a potential carcinogen. This is a serious matter because metformin is a potentially life-saving drug. It lowers glucose levels. The recall was issued by Nostrum Laboratories Inc. and includes metformin HCl extended-release tablets, USP 750 mg. According to the FDA, the tablets contain “nitrosamine, or NDMA, above acceptable limits in the recalled tablets.”

According to the U.S. Environmental Protection Agency, NDMA is an “organic chemical used to make liquid rocket fuel and it can be a byproduct of manufacturing, including pharmaceutical manufacturing.” 

This isn’t the first time NDMA has been found in drugs. In fact, it’s only the “latest in a series of metformin recalls linked to potentially cancer-causing contaminants in the drugs.” To date, NDMA has also been found in antacids and blood pressure drugs.

Fortunately, Nostrum hasn’t received reports of consumers experiencing adverse reactions from the drug. For now, the company is notifying distributors and “arranging for the return of the recalled product.” The specific lots affected by the recall include:

• 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

If you have additional questions or concerns about the recall, contact Nostrum at 816-308-4941 or quality@nostrumpharma.com.

Sources:

Another four lots of a diabetes drug recalled for having too much of a carcinogen

Type 2 diabetes drug metformin recalled due to contamination with possible carcinogen