In December 2019, three types of metformin were recalled in Singapore after the drugs were found to contain high levels of N-Nitrosodimethylamine (NDMA), a probable human carcinogen.
In February 2020, two additional metformin recalls were announced in Canada due to NDMA contamination.
NDMA has been known to make rocket fuel. NDMA continues to be an unintentional byproduct of certain manufacturing processes, as well as an environmental contaminant found in water and foods, including meats, dairy and vegetables.
Animal studies have linked NDMA exposure to liver disease, as well as an increased risk of certain tumors, including liver cancer, lung cancer, kidney cancer, and cancers of the gastrointestinal tract. According to the U.S. Centers for Disease Control’s Agency for Toxic Substances and Disease Registry, it is “reasonable to expect that exposure to NDMA by eating, drinking, or breathing could cause cancer in humans.”
The FDA continues to investigate the presence of the N-Nitrosodimethylamine (NDMA) impurity in metformin approved for sale in the U.S. FDA testing has found NDMA in certain lots of extended release (ER) metformin and is recommending companies recall lots with levels of NDMA above the acceptable intake limit of 96 nanograms per day.
If you or anyone you know may be taking or have taken Metformin., please contact Finkelstein Thompson LLP. You can reach us at email@example.com or call us toll-free at 1-844-280-5009.