Novartis AG’s Sandoz unit mentioned on Wednesday it was once halting distribution of its variations of the drug often referred to as Zantac in all its markets, together with the USA and Canada, after contaminants have been discovered within the heartburn drug.
The Swiss drugmaker’s steps apply an investigation by means of U.S. and Eu regulators into the presence of the impurity, N-nitrosodimethylamine (NDMA), within the drug, ranitidine, and a distribution halt in Canada introduced past due Tuesday.
Well being Canada mentioned it had asked makers of the drug to forestall distribution because it gathers additional information and consults with world well being regulators.
Branded variations of the drug similar to Sanofi SA’s Zantac are to be had for over the counter sale in Canada, whilst generic variations are to be had on the market each OTC and with prescription.
A distribution halt isn’t the same as a recall and implies that current inventory of the medication in pharmacies or retail outlets can nonetheless be offered.
Neither the U.S. Meals and Drug Management nor the Eu Drugs Company had requested sufferers to forestall taking the drug when the regulators mentioned ultimate week they have been reviewing the security of ranitidine.
Novartis mentioned in an emailed remark its step was once precautionary and ok measures “can be applied in alignment with related well being government as required.”