Zantac Lawsuit 2019 Update
On September 9, 2019, Valisure released a citizen petition calling on further testing and recall of all ranitidine products including Zantac due to NDMA contamination.
NDMA and similar cancer causing nitrosamine contaminants were already in the news, after other drugs such as Valsartan were discovered to contain NDMA. Other nitrosamine chemicals include N-Nitrosodiethylamine (NDEA) and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA).
The presence of NDMA and other nitrosamine chemicals had already caused the recall of many lots of Valsartan, and Valisure released new data showing similar NDMA issues with Zantac.
Who Makes Zantac?
First, generic Zantac is not sold as Zantac. The active drug ranitadine can be resold under many different store brand names. The companies manufacturing ranitidine include:
- Appco Pharma
- Golden State Medical Supply
- Lannett Company
- Northwind Pharmaceuticals (Denton Pharma)
- Novitium Pharma
- Sandoz (Novartis)
The store names of ranitidine that are recalled include:
- Zantac mint
- Zantac injection
How much NDMA is in Zantac?
Valisure tested drugs sourced from multiple manufacturers and stores, and found NDMA per tablet ranging from 2.5million ng to 3.27million ng per tablet. These levels are far above what is expected and acceptable as a risk from a heartburn over-the-counter medication.
FDA 2019 Warnings
The FDA 2019 warnings include the September 13, 2019 statement alerting patients and doctors about NDMA in ranitidine, the September 26, 2019 statement on recalls of some ranitidine medication in the United States, another October 28, 2019 update regarding more recalls, and a November 1st, 2019 update on laboratory testing results for NDMA in raitidine.
To read all of the FDA updates, see the FDA website dedicated to listing all of these updates in one location: FDA Zantac Ranitidine Update Page.