Anyone with an existing inventory of the product should quarantine the recalled lots immediately. It is an OTC and prescription drug; OTC ranitidine is approved to prevent and relieve heartburn associated with acid ingestion and sour stomach while prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.
Like the US FDA, CDSCO has so far not called for any halting of supplies or recalls, which means the products can continue to be marketed in the country. It will also give drug supply information to wholesalers, medical institutions, and pharmacies. According to the recall notice, the capsules have "elevated levels of NDMA, a probable human carcinogen formally known as N-nitrosodimethylamine". The agency is testing Zantac and its generic versions but has not asked drugmakers to recall the products. And Sanofi, which produces the brand-name Zantac, is not yet making any moves.
For now, the FDA is investigating ranitidine products from numerous manufacturers, including Sandoz Inc., to see "whether low levels of NDMA recently discovered in ranitidine pose a risk to patients".
London-based multinational pharmaceutical company GSK has informed a local importer of medicines that it has made a decision to withdraw four of its drugs sold under the brand name Zantac from the local market, the Health Bureau (SSM) said in a statement on Tuesday. This data is to be provided to the agency in 30 days.
Light said his company's testing simulated how the drug breaks down in the stomach. Manufacturing flaws were blamed for that, but in this case, experts say it's likely that enzymes in a person's body react with the ranitidine molecule and actually create NDMA. "This appears to be a fundamental problem with the molecule itself".
Subsequently, Saraca Laboratories Ltd was notified by the European Directorate for the Quality of Medicines (EDQM) that its certificate of suitability for ranitidine hydrochloride had been suspended with immediate effect.