OZON Farm withdrew ranitidine-containing drugs


The pharmaceutical manufacturer OZON Farm withdrew ranitidine containing drugs due to high potential risks when taking them, the company said.

“Due to the high potential risks of drugs containing MNN ranitidine, OZON Pharmaceuticals decided to withdraw this drug”,  the report said.

In April 2020, the U.S. Food and Drug Administration (FDA) required the withdrawal of ranitidine-containing drugs due to established risks associated with the N- nitrosodimethylamine (NDMA) impurity, which is classified as a carcinogen. The agency found that the content of potential NDMA carcinogen increases over time and at a certain storage temperature.

In April 2020, it was also withdrawn from the EU and Australian markets for the same reason.