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Zantac

The attorneys of Baldante & Rubenstein are representing individuals that took Zantac, (generic name – Ranitidine).

Zantac was commonly used in the treatment of peptic ulcer disease, gastroesophageal reflux disease, and Zollinger-Ellison syndrome, and who developed cancer.

In September 2019, the U.S. Food and Drug Administration (FDA) learned that some ranitidine medicines, including some products sold under the brand name Zantac, contained a nitrosamine impurity called N-nitrosodimethylamine (NDMA), classified as a probable human carcinogen, at low levels.

In September 2019, Sandoz issued a “precautionary distribution stop” of all medicines containing ranitidine, which was followed a few days later by a recall of ranitidine hydrochloride capsules in the United States.

Apotex recalled all over the counter (OTC) ranitidine tablets sold in the United States at Walmart, Rite Aid, and Walgreens. Subsequently, Walmart, Rite Aid, Walgreens, and CVS pulled Zantac and some generics from their shelves.

In October 2019, Sanofi recalled all over-the-counter Zantac in the United States and Canada, Perrigo issued a worldwide recall of ranitidine, Dr. Reddy’s issued a recall of all ranitidine products in the United States, and Novitium Pharma recalled all ranitidine hydrochloride capsules in the United States.

In an article in Law 360 in October 2019, it was reported that numerous consumer class action and individual personal injury lawsuits had begun being filed alleging that Sanofi and other drug companies knew that ranitidine metabolizes into unsafe levels of a possible carcinogen, NDMA, but failed to disclose the information to their customers. It was also reported that the FDA earlier that month stated that its preliminary tests had discovered NDMA and was further investigating the matter.

The allegations in filed lawsuits are that there is a defect in Ranitidine/Zantac that when ingested, it forms a potent carcinogen (NDMA) in the body that exceeds FDA permissible intake limits by thousands of times. Unlike with other drug lawsuits (i.e. Valsartan) where NDMA got in the drug by accident through a manufacturing problem, the Ranitidine/Zantac lawsuits allege that there is a fundamental problem with the pharmaceutical product itself in the way the chemical interacts with the human body.

In November 2019, the FDA advised companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake (96 nanograms per day or 0.32 parts per million for ranitidine). At the same time, they indicated that some levels of NDMA found in medicines still exceed what the FDA considers acceptable for these medicines.

In November 2019, Aurobindo Pharma, Amneal Pharmaceuticals, American Health Packaging, Golden State Medical Supply, and Precision Dose recalled some lots of ranitidine tablets, capsules, and syrup.

In December 2019, the FDA asked manufacturers of ranitidine and nizatidine products to expand their testing for NDMA to include all lots of the medication before making them available to consumers. In December 2019, Glenmark Pharmaceutical Inc., USA recalled some lots of ranitidine tablets.

In January 2020, Appco Pharma LLC and Northwind Pharmaceuticals recalled some lots of ranitidine tablets and capsules. In February 2020, American Health Packaging recalled some lots of ranitidine tablets manufactured by Amneal Pharmaceuticals.

If you or a loved one took Zantac (generic name – Ranitidine) and was diagnosed with cancer, please immediately call the attorneys of Baldante & Rubenstein so that we can provide a timely free consultation for you, properly investigate your claim, and obtain justice for you from the responsible party.

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