FDA says heartburn drug Zantac should be immediately pulled from shelves
The Food and Drug Administration on Wednesday said the heartburn drug Zantac should immediately be pulled from shelves and consumers should dispose of any pills or liquid they have at home.
During safety tests last summer, extremely high levels of the contaminant NDMA, believed to be a carcinogen, were discovered in samples of the drug. The active ingredient in Zantac is ranitidine, and the FDA said that over time, NDMA appears as an impurity in ranitidine in levels exceeding federal standards, NPR reports.
The FDA issued a warning last September, and CVS, Walgreens, and Walmart removed the drug and its generic forms from stores. Since then, the agency has confirmed that the issue is how ranitidine naturally breaks down in normal storage conditions, and has nothing to do with the way it is manufactured.
"We didn't observe unacceptable levels of NDMA in many of the samples that we tested," the FDA's Janet Woodcock said in a statement Wednesday. "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."
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