Sanofi SA stated Friday it would recall popular heartburn medicine Zantac in the U.S. and Canada after the drugs had been linked with a cancer-causing impurity.
The French drug producer said it was working with a health agency to understand the degree and extent of the recall, which it termed a prudent step being taken due to possible contamination with a substance called N-nitrosodimethylamine.
Sanofi has marketed over-the-counter Zantac in Canada and the U.S. since 2017. It’s pulling the drug off shelves after earlier recalls by several generic versions makers of the drug.
Sanofi posted Zantac sales of 127 million euros in 2018, 69 million euros during the first half of 2019.
U.S. and European health governors said in September they were reviewing the safety of ranitidine, which is usually sold as Zantac and its generic alternatives after an online pharmacy known as Valisure informed them that it had found impurities in the medication.
The U.S. Food and Drug Administration (FDA) stated earlier this month it found unacceptable levels of NDMA in medication containing ranitidine. The regulator asked ranitidine makers to carry out their testing to evaluate levels of the impurity and to send samples for examination by the company.
Canada has requested drug companies to halt the distribution of the drug while it gathers extra information.
Sanofi CEO Paul Hudson, speaking at a news conference in Framingham, Mass., earlier this week, downplayed concerns concerning the drug.
Different drug producers, along with GlaxoSmithKline and Novartis, have recalled or halted distribution of their versions of the medicines.