FDA announces yet another new recall for extended-release metformin due to contamination
The FDA has announced another voluntary recall for extended-release (ER) metformin, a common medication for treating patients with type 2 diabetes.
There have been numerous recalls for ER metformin in the last year. This latest recall, like the others, is due to unacceptable levels of N-nitrosodimethylamine (NDMA).
This recall, announced on the FDA’s website, is for a single lot of ER metformin manufactured by Kansas City, Missouri-based Nostrum Laboratories. The impacted lot is packaged in bottles of 100 tablets. The medication is “an off-white oblong tablet” with “NM7” on the side. The lot number is MET200601. More information is available here.
This is technically a second expansion of a recall originally announced in November 2020. The first expansion of that recall was announced in early January.
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 other voluntary recalls for this medication were announced back in October 2020.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.