April 1, 2020

FDA pulls Zantac products from the market with immediate effect

By Newsroom

The US Food and Drug Administration have requested that manufacturers pull all prescription and over-the-counter ranitidine drugs, known by the brand name Zantac, from the market immediately.

They made the announcement earlier today. According to the FDA an ongoing investigation has revealed that levels of a contaminant in the heartburn medications increase over time and when stored at higher-than-normal temperatures, pose a risk to public health.

The contaminant, N-nitrosodimethylamine or NDMA, is a probable human carcinogen and the FDA has been investigating levels of it in ranitidine since the summer of 2019.

According to Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research:

“However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured.  The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.”

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