Congresswoman DeLauro Letter to FDA On Ranitidine
On December 18, 2019, Congressman Rosa DeLauro sent a letter to the Food and Drug Administration (FDA) Commissioner Stephen Hahn and the Department of Health and Human Services (HHS) Secretary Alex Azar to recall drugs containing ranitidine due to high levels of N-Nitrososdimethylamine (“NDMA”), a probable human carcinogen.
On April 01, 2020, the FDA 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.
Read the full letter here.
