Patient safety and the quality of all our products is of the utmost importance to us. For that reason, as a precautionary measure, we are recalling at pharmacy level several batches of Sandoz ranitidine film-coated tablets across a number of markets, including Canada. Ranitidine is a generic medicine that is marketed globally by several pharmaceutical companies. Therefore, other pharmaceutical companies might also initiate recalls.
Already before the recall, a precautionary release and distribution stop of all our ranitidine-containing medicines in all our markets had been ordered by Sandoz and will remain valid until further clarification. These decisions follow the confirmation that traces of N-Nitrosodimethylamine (NDMA) above levels established by Health Canada and other Health Authorities internationally have been found in batches of Sandoz ranitidine film-coated tablets. Sandoz is actively investigating the root cause.
It is important that the medication be not discontinued without consulting the prescribing physician to ensure continuous treatment of the underlying disease for which the product was prescribed. Further availability of this key medicinal product for patients is a top priority for us and we are exploring possible options with Health Canada to cover patient needs.