FDA requests the withdrawal of Ranitidine (Zantac) from market

The Food and Drug Administration is requesting the withdrawal of prescription and over-the-counter ranitidine medications from the market. The medication is widely known by the brand name Zantac, a ranitidine product to treat heartburn.

The decision comes because the FDA says some ranitidine products contain increasing amounts of a likely human carcinogen through the passage of time as well as when exposed to temperatures in excess of room temperature.

The impurity is called N-Nitrosodimethylamine or NDMA for short.

"We didn’t observe unacceptable levels of NDMA in many of the samples that we tested," Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research said. "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.”