FDA Requests Removal of All Ranitidine Products (Zantac) from the Market

Date: 
Wednesday, April 1, 2020

The U.S. Food and Drug Administration today announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. 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 agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.

The full press release can be found by visiting the FDA's website

The Board recommends patients speak with their pharmacist or prescribers for further information.

Printed from the Iowa Board of Pharmacy website on August 06, 2020 at 11:09am.