Several companies have initiated recalls of extended release versions of the first-line type 2 diabetes treatment metformin due to unsafe levels of N-nitrosodimethylamine (NDMA), a probable human carcinogen.
On May 28, the Food and Drug Administration (FDA) informed the public that testing had revealed unacceptable levels of NDMA in some extended-release metformin products. The agency urged five companies to recall affected products. Recalls were initiated by the following manufacturers: Granules Pharmaceuticals, Lupin Pharmaceuticals, Avkare (repackager for Amneal), PD-Rx Pharmaceuticals (repackager for Amneal), PD-Rx Pharmaceuticals (repackager for Marksans), The Harvard Drug Group (repackager for Apotex), and Preferred Pharmaceuticals (repackager for Marksans).
The FDA has since created a searchable list of all recalled extended-release metformin products that includes manufacturer name, NDC numbers, lot numbers, and expiration dates for all affected products.
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