Metformin, a medication to treat type 2 diabetes, is facing a recall over concerns it has been contaminated with a possible cancer-causing substance.
Nostrum Laboratories Inc., the maker of Metformin, announced it is voluntarily recalling two lots of the medication – Metformin HCl Extended-Release Tablets, USP 750 mg – because the lots have been found to contain above-acceptable limits of nitrosamine, also known as NDMA, a “probable human carcinogen,” per the recall announcement posted to the U.S. Food and Drug Administration’s (FDA) website on Monday.
This isn’t the first time excess levels of NDMA in medications have prompted recalls. In the past, certain blood pressure and heartburn medications have been affected.
“NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables,” per the announcement.
No adverse events related to the recalled medications have been reported to date, the company said.
The affected medications are packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01, per the announcement on the FDA’s website. Lot numbers are MET200101 and MET200301. Both lots have an expiration date of May 2022.
“The product can be identified as an off-white oblong tablet debossed with ‘NM7.’ Metformin HCl Extended-Release Tablets, USP 750 mg was distributed nationwide to wholesalers,” per the announcement.
“Nostrum Laboratories Inc. is notifying its distributors by letter and is arranging for return of all recalled products. Pharmacies that have Metformin HCl Extended-Release Tablets, USP 750 mg, which is being recalled, should return to place of purchase. Consumers should consult a health care professional to obtain a replacement or a different treatment option,” the announcement reads. “It could be dangerous for patients with type 2 diabetes to stop taking their Metformin without first talking to their health care professional. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking this drug product.”
Consumers with additional questions can contact Nostrum Laboratories Inc. Medical Affairs at 816-308-4941 or email email@example.com.