Pharma recalls type 2 diabetes drug metformin due to possible carcinogen

Vigilance over medications is one thing that many consumers in the U.S. are thankful for. Many pharmaceutical companies issue voluntary recall whenever they detect that any of their products in the market could lead to potentially adverse health consequences. Recently, a pharma based in Kansas City in Missouri issued a voluntary recall after detecting high levels of a possible carcinogen in one of its medications.

In a recall posted by the U.S. Food and Drug Administration, Nostrum Laboratories Inc. announced that it is voluntarily recalling its type 2 diabetes drug metformin HCI extended-release tablets. Consumers must take note that the subject of the recall is the USP 750 mg.

The recall revealed that the said drug had high levels of N-Nitroso-dimethylamine (NDMA), otherwise known as nitrosamine. The levels were already beyond the acceptable limits for the said drug.

The U.S. Environmental Protection Agency (EPA), categorised NDMA as a possible carcinogen. The organic chemical could be a byproduct of pharmaceutical manufacturing. It is also found in antacid and a number of blood pressure drugs, as well as in food and water, including dairy, vegetables, and meat.

The pharma revealed that no reports of any adverse health effects have been forwarded to them. Still, the company has already informed its distributors and has made proper arrangements for the return of the recalled product.

Consumers and distributors must take note of the lots that were recalled. The products were packaged in HDPE bottles (100 tablets) under NDC 29033-056-01. More specifically, the affected ones are Metformin HCI Extended Release Tablets USP 750mg, with lots MET200101 and MET200301. The expiration date of the lots is 05/2022. The tablets are identifiable as they have the "NM7" mark, off-white and oblong-shaped.

The voluntary recall by Nostrum is just another of the number of recalls issued by pharmaceutical companies on their metformin tablets. Previously, an Indian pharma Marksans Pharma Limited also recalled its metformin hydrochloride extended-release tablets due to its high NDMA levels. In the said recall, it noted that NDMA is a probable human carcinogen and the levels in the drug were higher than the acceptable 96 nanograms per day.

Pharma Recalls Metformin