Drugmaker Mylan Pharmaceuticals, Inc. has issued a voluntary recall for three lots of the antacid Nizatidine (Axid) after traces of N-Nitrosodimethylamine (NDMA) were discovered in the active ingredient. Although no adverse events have been reported, Mylan is notifying all distributors, retailers, and customers, and has been making arrangements for the return of the affected products.
Last month, Drug Safety News featured a story about Valisure, a small, independent pharmaceutical testing lab in Connecticut that discovered carcinogenic NDMA in Zantac. It wasn't outside contamination – it was a problem with the molecule at the heart of the formulation.
With this week's revelations of NDMA contamination in the popular antacid Zantac (ranitidine), health authorities and scientists are asking just how it happened. Frighteningly, there is evidence to suggest that it may have been there all along.