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Novartis halts distribution of its Zantac versions amid probe into impurities

The drugmaker, Novartis, said the move is precautionary after a potentially dangerous substance was found.
/ Source: Reuters

Novartis AG’s Sandoz unit said on Wednesday it was halting distribution of its versions of the drug commonly 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 steps follow an investigation by U.S. and European regulators into the presence of the impurity, N-nitrosodimethylamine (NDMA), in the drug, ranitidine, and a distribution halt in Canada announced late Tuesday.

Health Canada said it had requested makers of the drug to stop distribution as it gathers more information and consults with international health regulators.

Branded versions of the drug such as Sanofi SA’s Zantac are available for over-the-counter sale in Canada, while generic versions are available for sale both OTC and with prescription.