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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.

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