FDA Wants All Ranitidine Products Off the Market

WASHINGTON -- All ranitidine products should be pulled from shelves immediately, the FDA said Wednesday, including brand-name Zantac as well as generic versions of the prescription and over-the-counter antacid.

Notably, this was not because of direct evidence of N-Nitrosodimethylamine (NDMA), a probable human carcinogen, being present in particularly high concentrations in the drug itself.

"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, MD, director of the FDA's Center for Drug Evaluation and Research, said in a statement.

https://www.medpagetoday.com/gastroenterology/generalgastroenterology/85740?xid=NL_breakingnewsalert_2020-04-01&eun=g313860d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=ZantacAlert_040120&utm_term=NL_Daily_Breaking_News_Active