The rantitide drugs were found to contain N-nitrosodimethylamine, classified as a probable human carcinogen.
The FDA warned that Sanofi’s popular brand-name drug Zantac was one of the drugs known to contain this impurity. Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Ranitidine is both an over-the-counter and prescription drug.
News of the impurity in a new drug comes as r the FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines for more than a year. Hundreds of blood pressure medications have been recalled as a result.
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