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The U.S. Food and Drug Administration today announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity.
Individuals are filing cases against Zantac’s manufacturer, Sanofi, claiming that they were exposed to extremely high levels of NDMA. You may be entitled to a substantial settlement if you took Zantac and you were diagnosed with any of the following:

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Zantac (Ranitidine) Carcinogen Contamination Leads To Recalls, Lawsuits

Dating back to July 2018, the United States Food and Drug Administration (FDA) has been providing public warnings about contamination in generic blood-pressure medications known as angiotensin II receptor blockers (ARBs). These medications which were found to be contaminated with substances known as nitrosamines, which have been identified as probable human carcinogens. Certain of these drugs have been subject to ongoing voluntary recalls, leading to shortages and price spikes.

FDA Announces Zantac Contamination

While the FDA continued to grapple with the scope and causes of the ARB contamination, in September 2019, the agency dropped another bombshell, announcing that NDMA, the first nitrosamine to have been detected in generic, had also been found in the popular heartburn medication Zantac as well as generic forms of the drug, known as ranitidine.
“FDA has learned that some ranitidine medicines, including some products commonly known as the brand-name Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels,” the FDA’s September 13 statement warned. “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on the results from laboratory tests.”


Sanofi, the current maker of over-the-counter Zantac, followed this revelation with an announcement on October 18 that it was recalling all over-the-counter Zantac in the United States.
“As a precautionary measure, Sanofi on Friday, October 18, initiated a voluntary recall of all Zantac OTC (over-the-counter) in the United States,” the company announcement reads. “This includes Zantac 150, Zantac 150 Cool Mint, and Zantac 75. Zantac tablets are an oral, over-the-counter product to prevent and relieve heartburn associated with acid indigestion and sour stomach.”
Sanofi added that it also had initiated a voluntary recall of Zantac products in Canada. The company seemed to blame the contamination on overseas suppliers.
“Active ingredients used in Sanofi’s ranitidine products outside of the U.S. and Canada are sourced from different suppliers,” the October 18 company announcement says, also highlighting the difficulty inherent in tracing the contamination back through the complex pharmaceutical supply train to its source.


Learn how we can help hold the makers of Zantac accountable. Call Fetterman & Associates today.