(Gray News) - The U.S. Food and Drug Administration announced Nostrum Laboratories, Inc. had expanded its voluntary recall of some of its Metformin HCl tablets.
One lot of the Metformin HCl Extended Release Tablets, USP 750 mg, generic equivalent to Glucophage Tablets, were found to have levels of N-Nitrosodimethylamine (NDMA) above the FDA’s guidelines for daily intake limit.
NDMA is classified as a probable human carcinogen based on results from laboratory tests, the FDA stated in the news release. It is a known environmental contaminant and found in water and foods.
The product is used, along with diet and exercise, to improve blood glucose control in adults with type 2 diabetes.
It is packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01. The lot number of the recalled medicine is MET200501, with an expiration date of 07/22.
Nostrum is notifying distributors to arrange for the return of all recalled products, the FDA stated.
Consumers were advised to consult a healthcare professional to obtain a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking Metformin without first talking to their healthcare professional.
People should contact their physician or healthcare provider if they have experienced any problems that may be related to taking the drug, the FDA said.
Consumers with medical questions regarding the recall can contact Nostrum’s medical affairs office at 816-308-4941 or email email@example.com Monday through Friday from 8 a.m to 5 p.m. CT.
Visit the FDA’s recall notice on its website for more information.