Nostrum Laboratories, Inc. and the FDA are expanding a recall for certain packages of the drug, Metformin.
The U.S. Food and Drug Administration and Nostrum Laboratories, Inc. recently announced an expanded voluntary recall for certain packages of Metformin HCI tablets. According to the notice, one lot in particular of the Metformin HCl Extended-Release Tablets, USP 750 mg “have levels of N-Nitrosodimethylamine (NDMA) above the FDA’s guidelines for daily intake limit.”
In the recall announcement, the FDA stated that NDMA is “classified as a probable human carcinogen based on results from laboratory tests.” Additionally, NDMA is a “known environmental contaminant sometimes found in food and water.”
The affected medication is designed to help improve blood glucose control in adults with type 2 diabetes. It’s most effective when used with diet and exercise.
According to the notice, the affected products have a lot number of MET200501. The tablets expire in July 2022 and are “packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01.”
For now, the company is coordinating with distributors to have the affected products returned. Consumers who have the recalled medication should meet with their doctor to discuss a different treatment option. It’s important to note that “it could be dangerous for patients with type 2 diabetes to stop taking Metformin without first talking to their healthcare professional.”
If you have questions or concerns about the recall, contact Nostrums medical affairs office at 816-308-4941 or email the company at quality@nostrumpharma.com.
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