Sanofi recalls Zantac in United States, Canada
Sanofi has issued a voluntary recall for its OTC Zantac in the United States and Canada over concerns of possible contamination with probable human carcinogen NDMA. The company said it was working with health authorities to determine the level and extent of the recall.
The Food and Drug Administration and Health Canada issued public statements on Sept. 13 noting that some ranitidine medicines, including Zantac, could contain low levels of NDMA, with requests for manufacturers to conduct tests. Sanofi said it decided to recall the products due to inconsistencies in preliminary test results of the active ingredient in the U.S. and Canadian products. The company noted that its ranitidine products elsewhere are sourced from different suppliers.
“Sanofi is committed to transparency and will continue to communicate results with health authorities from the ongoing testing, and work with them to make informed decisions based on available data and evidence,” the company said.