Drugs

Pull Zantac and Generics from Market: FDA

FDA is asking manufacturers to withdraw all prescription and over-the-counter ranitidine (Zantac and generics) products from the market immediately due to NDMA contamination that can increase over time. An agency news release says FDA has determined that the N-Nitrosodimethylamine impurity in some ranitidine products increases over time and when stored at higher than room temperature and may result in consumer exposure to unacceptable levels of the impurity.

The agency conducted laboratory tests in 2019 and found NDMA in ranitidine at low levels. It says it did not have enough scientific evidence then to determine whether individuals should continue taking the drug and so continued its investigation.

“New FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers,” the release says. “The testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.”

In addition to sending letters to all manufacturers of ranitidine products asking that they withdraw their products from the market, FDA is advising consumers to stop taking any tablets or liquid they currently have, dispose of them properly, and not buy any more.

Gupta Raises Concerns About Overton’s Independence, Ideology

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Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome