Apotox Inc., has issued a recall of all lots of its extended release version of the type 2 diabetes drug metformin due to the presence or possible presence of NDMA, short for N-nitrosodimethylamine, a probable carcinogen, Health Canada announced. It is the third recall of metformin products the Canadian drug regulator has announced since late February, following reports by an independent pharmacy that the impurity had been found in batches of various metformin products.
In March, Health Canada announced the recall of 26 lots of JAMP Pharma Corporation’s metformin. In February, the agency announced the recall of six lots of Ranbaxy Pharmaceuticals Canada Inc., metformin. Both were due to the presence of NDMA.
NDMA is a known environmental contaminant that is found in meats, dairy products, and vegetables. The U.S. Food and Drug Administration (FDA) considers up to 96 nanograms of NDMA per day safe enough for daily consumption. However, the agency cautioned, “sustained higher levels of exposure [to NDMA] may increase the risk of cancer in humans.”
Last fall, NDMA was found in several versions of the heartburn drug Zantac. Several products were recalled. On April 1, the FDA ordered the removal of all Zantac products after finding that the levels of NDMA in Zantac could increase to unsafe levels under normal storage conditions and put consumers at risk.
In December 2019, the FDA alerted U.S. citizens of reports that NDMA had been found in some metformin products by an independent pharmacy, and the agency would investigate the matter. At the time, no drugs were recalled. Health Canada, on the other hand, issued its first recall of suspect metformin in February. It wasn’t until June 11 that the FDA determined that some extended-release versions of metformin could contain unsafe levels of NDMA and called on five companies to issue recalls. Those companies, which recalled their drugs within weeks of the FDA’s announcement, include Apotex, Amneal, Marksans (labeled as Time-Cap), Lupinm, and Teva (labeled as Actavis).
Beasley Allen attorney Frank Woodson is actively investigating potential claims involving regular Zantac/ranitidine use that may have led to cancer of the stomach, colon, intestines, kidneys, or pancreas. If you or a loved one may have been affected, please contact us. Beasley Allen is not currently taking claims related to metformin.