Sanofi is voluntarily recalling all Zantac over-the-counter (OTC) medications in the United States because they contain NDMA, or N-Nitrosodimethylamine, at low levels. That compound is a probable human carcinogen.
This notice includes Zantac 150, Zantac 150 Cool Mint, and Zantac 75. This product is an oral, over-the-counter product available without prescription to prevent and relieve heartburn associated with acid indigestion and sour stomach.
The FDA issued a public statement on September 13, 2019, alerting the public that some ranitidine medications could contain NDMA at low levels. The government asked these companies to conduct testing on their products.
But there were inconsistencies in some preliminary test results of the active ingredient used in U.S. products, so Sanofi has decided to conduct this recall as the investigation continues. The first recall notice was posted on October 18, 2019. The active ingredients are sourced from different suppliers.
Sanofi is notifying its distributors and customers through email and their web site and will arrange for the return of all products. Wholesalers are being asked to immediately stop distribution. Retailers are asked to stop dispensing Zantac tablets. And consumers are asked to talk to their doctors or pharmacists about alternative options. Sanofi has also conducted a voluntary recall in Canada.
Anyone who has experienced any problem or issue with any FDA-regulated product can report that adverse event through the FDA’s MedWatch Adverse Event Reporting Program. You can report through their online program or by fax. This program is for consumers and healthcare professionals. The FDA uses this program and the data collected to maintain surveillance of its regulated products.
