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Zantac® Lawsuit Timeline

Following the Timeline of Ranitidine

Here is a timeline of the events regarding the discovery and resulting investigation of nitrosodimethylamine (NDMA) contamination in ranitidine products.

September 2019

In September 2019, an online pharmacy known as Valisure filed a Citizen Petition with the FDA because it discovered high levels of NDMA in ranitidine medications. In the petition, Valisure requested the FDA pull ranitidine products from shelves. It also requested that the agency created protocols for testing NDMA in ranitidine products. Despite the lack of an official FDA recall, major retailers such as CVS, Rite Aid, Walgreens, Kroger, Publix, and Walmart pulled Zantac and generic ranitidine products.

October 2019

After receiving the Citizen Petition, the FDA warned the public of potential dangers associated with Zantac and other ranitidine products. However, the agency did not initiate a recall and did not tell those who use ranitidine products to stop doing so. This reaction differed from other national agencies. For example, Canada, the United Kingdom, and other nations were quick to initiate recalls of ranitidine.

The FDA justified it’s slower response by claiming that it needed to investigate issues with ranitidine products in more depth before making an announcement. While it confirmed that an outside lab reported high levels of NDMA in ranitidine products, the FDA stated “unsuitable” testing methods could have produced inaccurate results. During this time, the FDA did acknowledge that NDMA levels in ranitidine were “unacceptable” and warned the public of its dangers.

In October 2019, Sanofi, the producer of Zantac in the United States, recalled the product. This action came weeks after other pharmaceutical companies stopped distributing ranitidine. Notably, Sanofi continued to sell Zantac in the United States after Canada forced the company to recall the product.

November 2019

In a second update, the FDA revealed that the levels of NDMA it found in ranitidine products was no higher than levels found in smoked or grilled meats. However, the agency also said that it needed to test the drugs in the human body to understand their potential danger fully.

April 2020

After over six months of testing, the FDA requested all retailers and manufacturers stop the sale of ranitidine products. By this time, almost all major retailers and manufacturers had halted the production and sale of ranitidine products. It also encouraged consumers to stop using ranitidine products for the first time. In its update, the FDA revealed that the situation was worse than expected.

The announcement revealed that not only do ranitidine products have high levels of NDMA, but they also had the potential to become even more dangerous the longer they were stored. The FDA found that “…the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity.”

In other words, dangerous ranitidine products such as Zantac have the potential to be even more of a threat to the consumers who use them as they sit on the shelf or in a medicine cabinet.

Arnold & Itkin LLP

About Ranitidine Lawsuits

While many pharmaceutical companies voluntarily pulled their ranitidine products from shelves by the time the FDA made its April announcement, the damage had already been done. Zantac began being sold in 1983 and had become the world’s best-selling drug by 1988. In 1997, the patent for ranitidine expired, causing dozens of affordable ranitidine brands to show up on store shelves.

Drug companies have a responsibility to make sure the products they produce are safe. They should never wait for the discoveries of an independent third party or the FDA to test for impurities. These companies must be held accountable and reminded that billions in profits aren’t more valuable than the health of their consumers.

Find Out If You Have a Zantac Claim Online!

If you believe you or a loved one suffered because of Zantac, help is available. At Arnold & Itkin, we have a history of holding some of the largest companies in the world accountable.Recently, we secured an $8 billion verdict against Johnston & Johnston. We’ve shown we never back down, that pharmaceutical companies aren’t immune to accountability, and that clients deserve answers.

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