Update: FDA names 5 companies recalling extended-release metformin
Back in May, the FDA announced that numerous lots of extended-release metformin were being recalled due to unacceptable levels of N-nitrosodimethylamine (NDMA), a contaminant associated with cancer.
“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 at the time. “Now that we have identified some metformin products that do not meet our standards, we’re taking action.”
On June 11, the FDA provided an update, sharing the names of all 5 companies involved in the metformin recall. While Apotex and Amneal are recalling all lots of the diabetes medication, Marksans and Lupin are recalling a single lot. Teva, meanwhile, is recalling a total of 14 lots.
“There are additional companies that manufacturer ER metformin and supply a significant portion of the U.S. market, whose products are not being recalled at this time,” according to the FDA. “Patients taking recalled ER metformin should continue taking it until a doctor or pharmacist gives them a replacement or a different treatment option.”
The agency’s full update is available here.
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.