Regulatory Guidance

Novartis stops distribution of Zantac amidst toxin probe

Sep 18, 2019

Novartis’ Sandoz unit has put the brakes on its distribution of a popular heartburn medicine as regulators investigate reports that it could be contaminated. 

Late last week, the FDA announced that traces of N-nitrosodimethylamine (NDMA), a possible carcinogen, were detected in several versions of Zantac (ranitidine) by an online pharmacy that tests drugs. 

As a precautionary measure, Sandoz said that it is now halting distribution of Zantac in all markets, including the U.S. and Canada. The FDA said it is reviewing the safety of ranitidine and hasn’t asked patients to stop taking the med. Unlike a recall, the distribution disruption will not impact sales of the drug currently on the market. 

Zantac is the fourth best-selling antacid in the America and pulled in $128.9 million in U.S. sales last year.

NDMA is one of the toxins related to the recent wide-spread recall of valsartan, a heart medication.

Read the Reuters report.