The U.S. Food and Drug Administration announced it is requesting manufacturers withdraw all prescription and over-the-counter ranitidine drugs, known by the brand name Zantac, from the market immediately, the agency announced on Wednesday.
This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac).
“The FDA is committed to ensuring that the medicines Americans take are safe and effective. We make every effort to investigate potential health risks and provide our recommendations to the public based on the best available science. We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. 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,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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.”
According to the FDA’s announcement, letters are now being sent to all manufacturers of ranitidine requesting that they withdraw products from the market, and consumers are advised to stop taking any ranitidine tablets or liquid medications they currently have. The FDA said to dispose of them properly and not buy more.
Due to the coronavirus pandemic, the FDA said don’t return your medicines to a “drug take-back location,” but rather follow disposal instructions in the medication guide or insert — or follow the FDA’s recommended safe disposal steps on its website.
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