The US Food and Drug Administration is considering whether recalls or manufacturing process changes are needed after a contaminant was found in drugs containing the active ingredient in Sanofi’s Zantac OTC heartburn remedy and multiple generic equivalents.
A similar probe is underway by the European Medicines Agency, which is working alongside the US regulator to find the cause of adulteration of OTC and Rx histamine-2 blocker (H2) drugs containing ranitidine with nitrosamine impurity called N-nitrosodimethylamine, or NDMA, the same contaminant that led to US