The pharmacy giant's decision raises a multitude of worldwide concerns about the drug after major manufacturers of the generic form, ranitidine, announced memories. The US Food and Drug Administration has also investigated the potential risk to patients.
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Sandoz, a division of pharmaceutical giant Novartis, stopped the distribution of ranitidine in mid-September and then announced that it remembered a lot of ranitidine after the impurities were discovered above acceptable levels last week. Apotex Corp., another manufacturer, recalled last week ranitidine tablets on a "precautionary basis" after learning from the FDA and other global regulators that the drug may contain the impurities, regardless of the manufacturer. Drug recalls are usually executed by individual manufacturers and then announced by the FDA.
The FDA has asked companies to test the levels of NDMA in their drugs and submit samples to the agency.
“The Agency is working with international regulators and industry partners to determine the source of this impurity in ranitidine. We are also working to understand what happens to NDMA levels in the body after the administration of ranitidine, ”said FDA spokesman Jeremy Kahn. "The FDA will take appropriate action based on the results of the ongoing investigation."
Sanofi, the drug company that produces ranitidine under the trade name Zantac, has not recalled the drug.
"The FDA reported that levels of N-nitrosodimethylamine (NDMA) in ranitidine in preliminary tests hardly exceed amounts found in regular foods," Ashleigh Koss, a Sanofi spokeswoman, told The Washington Post via email. " works closely with the FDA and conducts our own robust investigations to ensure that we continue to meet the highest quality standards for safety and quality. At Sanofi, we remain committed to being transparent with our patients and consumers and will share an update when available. "
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The FDA has informed patients to talk to their doctors about taking an alternative prescription for ranitidine, a heartburn medicine commonly used in prescription drugs and without prescription drugs to treat problems such as peptic ulcer and acid reflux.
Globally, Canada and France have already remembered Zantac, the BBC reports, while GlaxoSmithKline has recalled its ranitidine products in India and Hong Kong, according to USA Today (GlaxoSmithKilne does not sell rantidine products in the US).
Other pharmacy chains like Walgreens and Rite-Aid and distributors such as Walmart have already stopped selling Zantac in their stores. CVS did not immediately respond to a request for comment on the recall timeline or whether the company has ever stopped selling a product that has not been officially recalled by the manufacturer.
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