FDA announces a new recall for extended-release metformin due to contamination
The FDA has announced a new voluntary recall for extended-release (ER) metformin, a common medication for treating patients with type 2 diabetes, due to the detection of unacceptable levels of N-nitrosodimethylamine (NDMA).
Cranford, New Jersey-based Viona Pharmaceuticals is recalling 23 lots of Metformin Hydrochloride ER Tablets. The tablets, sold in bottles of 100, have expiration dates ranging from June 2022 to January 2023.
Click here for the full FDA advisory detailing this recall.
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.”
Additional voluntary recalls were announced in October 2020, November 2020 and January 2021.
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.