NEW YORK (Reuters) – Sanofi SA said on Friday that it would recall Zantac's popular heartburn medicine in the United States and Canada, after the medicines are linked to probable cancer causing probable.
FILE FILE: This picture illustration contains a bottle of Zburnac heartburn drugs taken 1 October 2019. REUTERS / Brendan McDermid / Illustration / Photo File
A French drug maker said he was working with health authorities to determine the level and extent of the recall, which he called a precautionary measure due to possible contamination with a substance called N-nitrosodimethylamine (NDMA).
The US and European health regulators last month said that they were reviewing departmental safety, which is commonly sold as Zantac and its variant alternatives, after being notified by an online pharmacy called Valisure. they impurities in the drugs.
The US Food and Drug Administration said earlier this month that it had found unacceptable levels of NDMA in ranididian drugs. The regulator asked regional manufacturers to carry out their own testing to assess levels of impurities and to send samples of their products for testing by the agency.
Canada asked drug manufacturers to stop the drug collecting more information.
Sanofi Zantac sold over the counter in the US and Canada since 2017.
CEO Sanofi, Paul Hudson, speaking at a press conference in Framingham, Mass., Earlier this week, expressed concerns about drugs.
“We don't believe there is a danger,” said Hudson on Tuesday. “But we will – and we have a proper duty – to satisfy the regulators, which we will do, and then we will move forward.” Other speakers including GlaxoSmithKline and Novartis distributed or stopped their versions of the drug.
Retailers and pharmaceutical chains including Walmart Health Corp Inc CVS, Walgreens Boots Alliance Inc. and Rite Aid Corp have sold over-the-counter heartburn drugs containing ranitidine.
Ranitidine is the latest drug to detect impurities that cause cancer. Regulators have been recalling some blood pressure and heart failure medicines since last year.
Reported by Michael Erman, edited by Louise Heavens
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