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Zantac Recalled by Sanofi Due to NDMA Presence

Oct 21, 2020
Shamis & Gentile, P.A.
Zantac Recall due to high levels of NDMA

The popular and well-known drug Zantac has been recalled by its makers, Sanofi, due to the presence of elevated levels of NDMA in their product. This recall was made all-encompassing in April of 2020, when the FDA announced that all manufacturers of ranitidine products, including Zantac, were being recalled due to safety concerns. This broad recall came on the heels of several voluntarily recalls, including a recall by Sanofi of specific Zantac lots in October of 2019 and then again in February of 2020.

In their October 2019 recall announcement, Sanofi said:

“Sanofi is committed to transparency and will continue to communicate results with health authorities from the ongoing testing, and work with them to make informed decisions based on available data and evidence.”

The fall of 2019 recalls were related to the findings of Valisure, a pharmaceutical company that conducts independent tests for a variety of different drugs. Earlier in 2019, Valisure tested a variety of ranitidine medications–including Zantac–and found startlingly high levels of NDMA. NDMA is a compound which is believed to raise the risk for certain types of cancers.

After these findings were submitted to the FDA, the FDA originally announced a warning of potential contamination in Zantac products in September of 2019. At this time, however, they did not announce a recall but confirmed they would be conducting further testing. Although the FDA themselves did not announce a recall at this time, many pharmacies conducted voluntary recalls and pulled Zantac and similar products from their shelves.

The FDA’s later testing found that not only was NDMA present in unacceptable levels in Zantac and other ranitidine medications, but that the NDMA levels were shown to increase even when the medication was stored at room temperature and in otherwise stable conditions. This startling finding indicates that the level of NDMA will inherently increase even if the medication is stored properly.

Zantac and Cancers

Since high levels of NDMA are associated with higher risks of cancers, it is possible that users of Zantac may have developed cancers after taking the medication. Some of the cancers associated with Zantac include bladder cancer, liver cancer, esophageal cancer and more.

Zantac Lawsuit Investigation

Due to the confirmed presence of elevated levels of NDMA in Zantac, a variety of Zantac lawsuit investigation actions are ongoing. Some lawsuits are arguing that Sanofi knew about the potential elevated levels of NDMA but did not warn consumers. These lawsuits are intended to help people who were diagnosed with cancer after taking Zantac to receive proper compensation for medical bills, lost wages, as well as compensation for physical and mental pain.

If you have been impacted by the Zantac recall, you may be eligible for a Zantac lawsuit investigation. Please contact your professional Zantac Lawyers, Shamis & Gentile, P.A. for a free case review at our email [] or feel free to call us today at 305-479-2299.

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