FDA mandates halt to distribution of ranitidine (Zantac) due to potentially carcinogenic contamination

After previously warning consumers and doctors last September that it had found measurable amounts of the carcinogen NDMA (N-notrisodimethylamine) in samples of the widely-used heartburn medication Zantac, the U.S. Food and Drug Administration has now ordered manufacturers to immediately stop distributing all versions of the drug over new concerns that small amounts of the poison can increase in the drug when it is stored above room temperature.

While it acknowledged that they had not found unacceptible amounts of NDMA in all samples of Zantac they had earlier tested, the FDA’s new statement highlights the fact that since they don’t know how long any given stores of Zantac have been stored and under what conditions, the medication should be removed from the marketplace “until its quality can be assured.”

Law360 (subscription) has noted that, “Consumers who still have the drugs should not return them to take-back locations in light of stay-at-home orders to prevent the spread of the coronavirus, the agency cautioned, asking patients to follow FDA guidelines for home disposal.”

The FDA made it clear that other similar drugs like Pepcid and Nexium have not shown any signs of contamination.

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