www.fdanews.com/articles/195796-fda-update-on-metformin-ndma-investigation-rules-out-recalls
FDA Update on Metformin NDMA Investigation Rules Out Recalls
February 7, 2020
The FDA said it found no metformin products that exceeded daily intake limits of N-Nitrosodimethylamine (NDMA) so it did not recommend recalling the type 2 oral diabetes drug in the U.S.
The agency’s investigation tested 16 lots of metformin products from seven different drugmakers: Actavis, Aurobindo, Heritage, Ingenus, Major, Sun Pharma and Westminster Pharmaceuticals.
All samples came back clean except for six Actavis lots that tested positive but for very low amounts.