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What You Need to Know About The Ranitidine Recall

by Whitfield Bryson | Consumer Products | Share

Chemically known as ranitidine hydrochloride, you’ve probably heard of the popular antacid medication Zantac as it’s been on the market since the early 1980s. The drug is available over the counter (Zantac OTC) and by prescription. People commonly use it for acid reflux, heartburn, and other gastrointestinal issues.

Ranitidine Recall Details

On Sept. 13, 2019, the U.S. Food and Drug Administration (FDA) issued an advisory warning the public of the increased risk of cancer due to chemical contamination of the heartburn medications containing ranitidine. Medicines containing ranitidine, including popular heartburn drug Zantac, were found to contain potent carcinogen n-nitrosodimethylamine (NDMA). NDMA was also the carcinogen that led to the July 2018 recall of valsartan and losartan, two popular blood-pressure-lowering medications. Since the initial drug recall in September, there have been at least nine additional recalls for this drug, leading pharmacies to pull both brand name and generic medications containing ranitidine from their shelves.

Despite the manufacturers of the drugs downplaying the risks at first, testing has revealed toxic levels between 3,000 and 26,000 times higher than what the FDA considers safe. Zantac was prescribed more than 15 million times a year prior to this FDA announcement. The FDA has since extended its recall to nizatidine, a similar drug.

Drug manufacturers Sanofi and Boerhringer Ingelheim manufactured, marketed, and sold a medication they knew or should have known was contaminated with an industrial chemical known to cause cancer. Regardless of how this particular contamination occurred, numerous studies since the 1980s have demonstrated a link between the NDMA in Zantac and cancer. Notably, when ranitidine comes into contact with water, it creates a chemical reaction that causes the formation of NDMA.

The following pharmaceutical manufacturers have voluntarily recalled Ranitidine products:

  • Amneal Pharmaceuticals, LLC
  • Apotex Corp.
  • Aurobindo Pharma USA, Inc.
  • Reddy’s Laboratories Ltd.
  • Lannett Company, Inc.
  • Novitium Pharma LLC
  • Perrigo Company plc
  • Sandoz Inc.
  • Sanofi

Zantac Recall Lawyers

The FDA has advised people who take over-the-counter versions of Zantac to consider using another heartburn medication. Patients who take prescription Zantac are advised to speak with their doctor before switching to something else.

If you took Zantac and developed stomach cancer, bladder cancer, or another cancer, please contact the dangerous drug lawyers of Whitfield Bryson LLP today.


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