Brand name Zantac is made by Sanofi Pharmaceutical. It is classified as a probable human carcinogen.The FDA said it's evaluating whether the low levels of NDMA in ranitidine pose a risk to patients and that it will post that information when it's available.Large amounts of NDMA may pose a risk, but the levels of NDMA in ranitidine found in preliminary tests barely exceed amounts found in common foods, according to the FDA.Copyright 2019 United Press International, Inc. (UPI).
said in September that the contaminant found in samples of Zantac was a type of nitrosamine called N-nitrosodimethylamine, or NDMA, which is believed to be carcinogenic in humans and is found in a variety of products, including cured meats. Walmart halted all sales of Zantac and generic versions of ranitidine after the FDA report.NDMA is the same contaminant found in many brands of blood pressure and heart failure medicines during the past year, leading to recalls. BRIDGEWATER, N.J., Oct. 18, 2019 /PRNewswire/ -- As a precautionary measure, Sanofi will conduct a voluntary recall of Zantac OTC (over-the-counter) in the U.S. and Canada.This recall is being taken due to possible contamination with a nitrosamine impurity called N-nitrosodimethylamine (NDMA). Zantac Recall Widens as Sanofi Pulls Its Drug Over Carcinogen Fears.
criticized Valisure’s testing methods, saying the results were invalid because the pharmacy heated the product, which created the higher levels of NDMA.Sanofi said that the recall applied only to the United States and Canada, and that its products sold outside the two countries were sourced from different suppliers.The F.D.A. NDMA is an environmental contaminant found in water and foods, including meats, dairy products and vegetables. The FDA said preliminary tests found low levels of the nitrosamine impurity N-nitrosodimethylamine in some ranitidine products.The medication is used to treat heartburn, ulcers and other stomach issues. "Sanofi takes patient safety seriously, and we are committed to working with the FDA," the company said in a statement. Pharmaceutical company Sanofi announced Friday it's recalling over-the-counter Zantac a month after the Food and Drug Administration said the heartburn drug contains small amounts of a carcinogen.. Sanofi described the voluntary recall as a "precautionary measure." "Evaluations are ongoing on both drug substance (active ingredient) and finished drug product," The announcement comes nearly three weeks after Apotex, the maker of a generic version of the drug issued its own recall. It is the same contaminant that The F.D.A. “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.The F.D.A. The eight lots of 150mg Zantac tested at 0.07 to 2.38 ppm and 0.01 to 0.36 micrograms. The company is working with health authorities to determine the level and extent of the recall. Apotex Inc. ranitidine recall (2019-09-24) Sanofi Consumer Health Inc. Zantac recall (2019-10-18) Pharmascience Inc. ranitidine recall (2019-10-25) Vita Health Products Inc. ranitidine recall (2019-10-25) Health Canada updates Canadians on its ongoing assessment of nitrosamine impurities in certain drugs (2019-12-02) Patients who take prescription Zantac are advised to speak to their doctor before switching to something else.Zantac Recall Widens as Sanofi Pulls Its Drug Over Carcinogen FearsPackages of Zantac on a drugstore shelf in New York City in September. Any reproduction, republication, redistribution and/or modification of any UPI content is expressly prohibited without UPI's prior written consent., source The company’s announcement follows decisions by Walgreens, CVS and others to remove the drug from their shelves and after other manufacturers recalled their products.The French drug maker Sanofi said Friday that it was recalling the over-the-counter heartburn drug Zantac in the United States and Canada, a month after the Food and Drug Administration Several manufacturers of generic versions of Zantac, called ranitidine, had already recalled their products, andIn a statement, Sanofi said it was investigating the issue. has advised people who use over-the-counter versions of Zantac to consider using another heartburn medication. The scope of the recall, which Sanofi said it was taking as a precautionary measure, has not yet been determined. … The company said it's working with federal health officials to determine the extent of its recall.
The company’s announcement follows decisions by Walgreens, CVS and others … Sanofi said it will voluntarily recall Zantac as the drugmaker and FDA investigate the source of NDMA, a probable carcinogen. Sanofi is working with the US Food and Drug Administration to determine the extent of the recall. Walmart, CVS, Walgreens pull Zantac and similar heartburn drugs because of cancer worries "Zantac OTC (over the counter) has … Zantac pulled by CVS over known carcinogen 00:30