The FDA has announced another voluntary recall of extended-release (ER) metformin, a common medication for treating type 2 diabetes, due to the detection of unacceptable levels of N-nitrosodimethylamine (NDMA).
Kansas City, Missouri-based Nostrum Laboratories is recalling two lots of ER metformin tablets that had been distributed to wholesalers throughout the United States. The lot numbers are MET200101 and MET200301.
Nostrum Laboratories has made plans to notify all affected distributors by letter, and arrangements are being made for the return of all recalled tablets.
“Consumers should consult a healthcare professional to obtain a replacement or a different treatment option,” according to the official announcement. “It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their healthcare professional. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.”
A bit of context
The FDA first announced the detection of high levels of NDMA, a contaminant associated with cancer, in ER metformin products in May 2020.
“We understand that patients may have concerns about possible impurities in their medicines, and want to assure the public that we have been looking closely at this problem over many months in order to provide patients and health care professionals with clear and accurate answers,” Patrizia Cavazzoni, MD, acting director of the FDA’s center for drug evaluation and research, said in a statement at the time. “Now that we have identified some metformin products that do not meet our standards, we’re taking action. As we have been doing since this impurity was first identified, we will communicate as new scientific information becomes available and will take further action, if appropriate.”
Two additional voluntary recalls were announced back in October.
Visit the FDA’s website for a full list of recalled ER metformin products.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.