The manufacturer of a generic form of the heartburn drug Zantac, Novartis, will cease distribution of the medicine after investigations suggested that generic and branded versions contain a known carcinogen. A distribution halt is not the same as a full recall, and generic Zantac (ranitidine) remaining on store shelves can still be sold, CBS News reported.
In a statement, the FDA said that a substance that can cause had been found in some ranitidine heartburn and ulcer medicines, including the brand name drug Zantac.
Sanofi, the maker of Zantac, said in a statement on Wednesday that “there are currently no plans to stop distributing or manufacturing Zantac or other ranitidine products outside of Canada,” and added that “we are conducting our own robust investigations to ensure we continue to meet the highest quality safety and quality standards.”
Levels of the nitrosamine impurity N-nitrosodimethylamine (NDMA) in some ranitidine products, the FDA said last week that this does not mean patients taking the drugs should now stop using them.
Several drugs are approved for the same or similar uses, the FDA noted.