Zantac heartburn pills are seen in this picture illustration taken October 1, 2019. — Reuters pic
The French drugmaker said it was working with health authorities to determine the level and extent of the recall, which it called a precautionary measure being taken due to possible contamination with a substance called N-nitrosodimethylamine . The US Food and Drug Administration said earlier this month it found unacceptable levels of NDMA in drugs containing ranitidine. The regulator asked ranitidine makers to conduct their own testing to assess levels of the impurity and to send samples of their products for testing by the agency.Sanofi has sold over-the-counter Zantac in the US and Canada since 2017.
“We don’t believe there’s a risk,” Hudson said on Tuesday. “But we have to — and are appropriately duty bound to — satisfy the regulators, which we will do, and we’ll move on from there.”