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Zantac FDA Recall Update

On April 1, 2020, the Food and Drug Administration announced that all manufacturers of Zantac and the generic forms of Zantac are to withdraw them from the market effective immediately. 

During their investigation, the Food and Drug Administration found that the N-Nitrosodimethylamine (NDMA) in some Zantac drugs “increases over time when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels…” NDMA is a known carcinogen. 

What Exactly is Zantac?

Zantac is a heartburn medication and is a trading name for Ranitidine. This medication is normally used in the treatment and prevention of ulcers of the stomach and intestines as well as gastroesophageal reflux disease, Zollinger-Ellison syndrome, acid indigestion, heartburn, and peptic ulcer disease.

It is available as a prescription or over the counter and belongs to the histamine-2 blockers class of drugs.

Have There Been Food and Drug Administration Warnings About Zantac? 

On September 13, 2019, the Food and Drug Administration issued an advisory regarding Zantac/Ranitidine after learning that NDMA is an active ingredient in Zantac.

Is There a Cancer Risk Associated with Zantac?

Yes. NDMA has the potential to be hepatotoxic, and the exposure to NDMA has been linked to several types of cancer, including: 

  1. Bladder Cancer
  2. Esophageal Cancer
  3. Gastric Cancer
  4. Liver Cancer
  5. Pancreatic Cancer

What Are the Zantac Lawsuits About?

The manufacturers of Zantac are now facing class-action lawsuits that allege that Zantac contains unsafe levels of NDMA, a cancer-causing substance.   

Have the Lawsuits Against Zantac Been Consolidated? 

As of February 10, 2020, 15 of the Zantac lawsuits have been transferred to the South Florida Court, and multidistrict litigation has been filed.

The transfer order states that there are currently 126 Zantac lawsuits pending in 21 districts across the United States. U.S. District Judge Robin Rosenberg has been assigned to the Zantac lawsuits in the U.S. District Court for the Southern District of Florida.

Have the Manufacturers of Zantac Been Damaged by the Lawsuits? 

Yes. As of February 17, 2020, Sanofi, one of the largest pharmaceutical companies in the entire world, took a $186 million write-down on Zantac after they recalled the drug in October of 2019. Sanofi is one of many manufacturers who’ve been damaged by the mass recall of Zantac. 

Additionally, the following companies have recalled their own versions of Zantac. They include: 

  • American Health Packaging
  • Amneal Pharmaceuticals
  • Aurobindo Pharma USA
  • Apotex Corp. (this includes over-the-counter Ranitidine tablets 75 mg and 150 mg,

 labeled by Walgreens, Walmart, and Rite-Aid)

  • Appco Pharma
  • Denton Pharma (dba Northwind Pharmaceuticals)
  • Reddy’s Laboratories (this includes Zantac over-the-counter OTC medicines

 labeled by retailers such as Walgreens, Walmart, CVS, Target, and Kroger)

  • GlaxoSmithKline (GSK)
  • Glenmark Pharmaceuticals
  • Golden State Medical Supply
  • Lannett Company
  • Novitium Pharma
  • Perrigo Company
  • Precision Dose
  • Sandoz
  • Sanofi

Why Should I Choose The Jeffcoat Firm to be My Zantac Lawyers?

At The Jeffcoat Firm, our team of Zantac attorneys is available to discuss the individual circumstances surrounding your case. We are proud to offer our clients a free no-obligation consultation so we can properly review your case and inform you of the next steps that may be taken in order to ensure you receive all the monetary compensation you may deserve.  

If you or a loved one has taken Zantac and been diagnosed with cancer, don’t hesitate to contact our office.

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! NOTICE ! No Legal Advice Intended. This website includes general information about legal issues and developments in the law. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and must not be taken, as legal advice on any particular set of facts or circumstances. You need to contact a lawyer licensed in your jurisdiction for advice on specific legal issues or problems.

Michael Jeffcoat, 1333 Main Street, Suite 510 Columbia, SC 29201
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