Novartis stops distribution of Zantac heartburn medication due to pollution

Novartis AG's Sandoz unit said on Wednesday it stopped the 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 drug manufacturer's steps follow an investigation by US and European regulators into the presence of the impurity, N-nitrosodimethylamine (NDMA), in the drug, ranitidine, and a distribution shutdown in Canada announced late Tuesday.

Health Canada said it had asked manufacturers of the drug to stop distribution as it gathered more information and consulted with international health authorities.

Brand versions of the drug such as Sanofi SA's Zantac are available for sale without sale in Canada, while generic versions are available for sale both OTC and prescription.

Distribution stop is different from recall and means that existing stock of medicines in pharmacies or stores can still be sold. [1[ads1]9659006] Neither the US Food and Drug Administration nor the European Medicines Agency had asked patients to stop taking the drug when regulators last week said they were assessing the safety of ranitidine.

Novartis said in an e-mail statement that the step was precautionary and adequate measures "will be implemented in accordance with relevant health authorities as needed."