As a result of FDA tests that found traces of N-nitrosodimethylamine, or NDMA, in Zantac and other forms of ranitidine, major drug manufacturer Sanofi voluntarily issued a recall of the popular heartburn medication. Here, the pharmaceutical liability attorneys at Sullivan Papain Block McGrath Coffinas & Cannavo, P.C. provide recent updates on this massive recall as well as what consumers should do if they have been affected by heartburn drug Zantac and generic ranitidine.
FDA Discovers Traces of NDMA in Heartburn Medication Zantac and Other Generic Ranitidine
Ranitidine is a popular antacid and antihistamine used to treat and prevent a host of stomach acid-related conditions such as heartburn, stomach ulcers, gastroesophageal reflux disease (GERD) and more. Zantac, which is a popular brand of ranitidine produced by Sanofi, was recently found to contain traces of probable human carcinogen NDMA.
NDMA is an impurity that can be unintentionally incorporated into medications during processing, as certain chemical reactions occur during manufacture that can expose the medication to the impurity. According to the US Environmental Protection Agency (EPA), NDMA is a probable human carcinogen that has the potential to negatively impact human health.
Sanofi Issued a Voluntary Recall After NDMA was Found in Zantac
As a response to the discovery of NDMA in batches of Zantac, drugmaker Sanofi issued a voluntary recall of the heartburn drug. The recall, which was issued on Friday, October 18th, will pull Zantac from shelves in the United States and Canada, and the recall follows FDA testing that found levels of NDMA that exceeds the amount of NDMA found in certain grilled and cured meats, another common source of the impurity.
Regarding the recall, Sanofi officials said in a statement, “Due to inconsistencies in preliminary test results of the active ingredient used in the U.S. and Canadian products, Sanofi has made the decision to conduct the voluntary recall in the U.S. and Canada as the investigation continues.”
Zantac Recall Follows the Halt in Distribution of Ranitidine by Drugmaker Novartis
The recent recall of Zantac by drugmaker Sanofi follows drugmaker Novartis’ halt in the distribution of their generic ranitidine made by Sandoz in September. Ranitidine sales were suspended as a result of the possibility the medication contained NDMA. To learn more about the halt in shipment of generic Zantac, click here.
Due to the recent discovery of NDMA in ranitidine as well as Zantac, the FDA will continue investigating the potential for NDMA contamination in commonly prescribed pharmaceutical medications.
Discuss Your Legal Rights with a Pharmaceutical Liability Attorney at SPBMC
The dedicated pharmaceutical liability attorneys at Sullivan Papain Block McGrath Coffinas & Cannavo, P.C. advocate for victims of negligent practices by major drugmakers who have a social responsibility to uphold and prioritize public health. If you or a loved one have taken or is currently taking Zantac or a generic form of ranitidine and would like to discuss your legal rights, contact the team of New York pharmaceutical liability attorneys at Sullivan Papain Block McGrath Coffinas & Cannavo, P.C. today.