Legal Helpline Zantac
In April 2020, the U.S. Food and Drug Administration (FDA) requested the removal of all ranitidine products from the market. The request included all prescription and over-the-counter ranitidine drugs due to an ongoing investigation of a carcinogenic contaminant known as N-Nitrosodimethylamine (NDMA). Ranitidine is commonly known by the brand name Zantac.
The FDA has determined that NDMA in some ranitidine products increases over time and when stored at higher than room temperatures, exposing consumers to unacceptable levels of NDMA, far greater than levels the agency considers to be safe.
NDMA is a known carcinogen, which can increase the risk of:
- Gastric cancer
- Liver cancer
- Colorectal cancer
- Bladder cancer
- Esophageal cancer
- Lung cancer
- Pancreatic cancer
What is Zantac?
Ranitidine (Zantac) is an H2-receptor blocker drug commonly used to treat conditions that cause excess stomach acid. It is available in over the counter and prescription forms. Zantac is used to relieve the symptoms of:
- Gastroesophageal reflux disease (GERD), also known as heartburn
- Gastritis (inflamed stomach) caused by inflammation, excess stomach acid, and peptic ulcers
September 2019: The independent testing laboratory Valisure discoved NDMA during routine testing of Zantac and alerts the FDA about concerning amounts of the carcinogen. The agency alerted the public without taking action.
Novartis AG stopped distribution of its generic ranitidine, and Canada requested all manufacturers stop distributing ranitidine products.
CVS, Walgreens, Rite Aid, and other major U.S. retailers removed ranitidine products from their shelves.
A class action lawsuit was filed in the Northern District Court of California, accusing Sanofi Aventis, the manufacturer of Zantac, of failing to warn consumers of the dangerous levels of NDMA in their product.
The FDA confirmed “unacceptable levels” of NDMA. The agency requested manufacturers stop sales. By the end of the month, many distributors had recalled products or stopped sales. Sanofi, the manufacturer of over-the-counter Zantac issued a voluntary recall.
The FDA requested the removal of all ranitidine (Zantac) products from the U.S. market after new studies demonstrated risks to public health. Studies demonstrated NDMA levels could increase the longer products are on the shelf, becoming more carcinogenic with time.
If you or a loved one has been harmed due to the use of Zantac, you may be entitled to significant compensation for your injuries.
Contact Legal Helpline for a free case review, or visit zantaclegalservices.com for more information.