FDA announces new recall for extended-release metformin due to contamination
The FDA has announced yet another voluntary recall of extended-release (ER) metformin, a common medication for treating patients with type 2 diabetes. The recall is due to unacceptable levels of N-nitrosodimethylamine (NDMA).
Numerous recalls for ER metformin occurred in 2020; this is the first of 2021.
This latest voluntary recall involves one lot of ER metformin manufactured by Kansas City, Missouri-based Nostrum Laboratories. It is technically an expansion of a recall originally announced in November 2020.
The impacted lot is packaged in bottles of 100 tablets, and the medication is off-white with “NM7” on the side. The lot number is MET200501. More information is available here.
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 2020, and then the initial Nostrum Laboratories recall was announced in November 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.