Sandoz, the generics and biosimilar subsidiary of Novartis, released a statement that escalates its action to counter possible contamination of ranitidine medicine by beginning the recall of ‘several batches’ of Sandoz’ ranitidine film-coated tablets across ‘a number of markets’.
Previously, the company had announced that it would be instigating a distribution stop of all ranitidine-containing medicines, in all markets.
Sandoz’ actions are due to the discovery by online pharmacy, Valisure, during its own investigation, that ranitidine medicine could be contaminated with N-nitrosodimethylamine (NDMA). The chemical is a probable human carcinogen, which featured as the first contaminant discovered during the ongoing sartan investigation.
In response to Valisure’s findings, both the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) acknowledged the potential for contamination and began their own investigations into ranitidine-containing medicine.
Due to the warnings, the spokesperson for Sandoz told us, “As part of industry-wide recalls of ranitidine medicines, we are recalling at pharmacy level… [The] decision follows the confirmation that traces of NDMA above levels established by Health Authorities have been found in batches of Sandoz ranitidine film-coated tablets.”
Sanofi produces the branded ranitidine product, Zantac, but a spokesperson the company told us it had “no plans to stop distributing or manufacturing Zantac or other ranitidine products outside of Canada.”
Further than this, the spokesperson stated that the company is working closely with the FDA and conducting its own investigation.
Health authorities react
Health Canada, the department of the Canadian government responsible for public health, reacted to the unfolding events by requesting manufacturers cease distribution of ranitidine medicine.
The authority noted that it was an ‘interim, precautionary measure’ as more information is gathered by the investigation, in conjunction with international regulators.
So far, the EMA and FDA have not issued their own request for distribution of such products to be halted but have posted a public acknowledgement of the issue.