BRIEF—FDA calls for all ranitidine products be pulled from the market

The US 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.

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, a probable human carcinogen.

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 USA.