Novartis AG’s Sandoz unit said Wednesday it was halting distribution of its versions of the ranitidine drug known as Zantac in all its markets, including the United States and Canada, after contaminants were found in the heartburn drug.
The Swiss drugmaker’s decision follows an investigation by U.S. and European regulators into the presence of the impurity, N-nitrosodimethylamine (NDMA), in the ranitidine drug and a distribution halt in Canada announced late Tuesday.
“Current evidence suggests that NDMA may be present in ranitidine, regardless of the manufacturer. As a result, and at Health Canada’s request, companies marketing ranitidine products in Canada have stopped any further distribution until evidence is provided to demonstrate that they do not contain NDMA above acceptable levels,” the regulator said.