WASHINGTON (WMTV) -- The Food and Drug Administration wants all ranitidine medications, which are commonly sold under the brand name Zantac, pulled from the shelves as soon as possible.
On Wednesday, the FDA requested all manufacturers of prescription or over-the-counter varieties to withdraw them immediately. The move comes as the federal agency continues to investigate a contaminant known as N-Nitrosodimethylamine (NDMA) that is in them, it said.
“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,” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, explained.
The FDA considers NDMA a probable carcinogen. Last year, the agency learned an independent laboratory found it in ranitidine. In September, it urged people who are taking ranitidine to consider alternative treatments. Its new testing indicates the amount of NDMA in the medicine increases under normal storage conditions and even faster at higher temperatures.
Because of the coronavirus pandemic, the FDA warns people with leftover medications not to return them to a drug take-back facility. Instead, they should follow the steps on the medication guide of follow its recommended steps.