Several countries have issued a recall for both prescription and over-the-counter Zantac, including the United States, Canada, Australia, and Hong Kong. The recalls came after Valisure conducted a study of Zantac and other generic forms of ranitidine and discovered the drug contained N- nitrosodimethylamine (NDMA), a chemical that is a probable human carcinogen. After the company identified the harmful chemical in the drug, it notified the U.S. Food & Drug Administration (FDA) in June of 2019.
Then, on September 13, 2019, Valisure filed a petition with the FDA and requested that the agency issue a recall for all products that contained ranitidine, including Zantac. After the FDA was made aware of the issue and received the petition, it began conducting its own laboratory tests and confirmed the existence of NDMA in ranitidine products. Because the FDA did not have enough evidence at the time to support a full recall, it continued with its investigation and warned the public in September 2019 that there may be potential risks associated with taking ranitidine products.
The FDA also recommended that the public consider taking other medications to treat heartburn, indigestion, and any other gastrointestinal conditions they were seeking relief for.
FDA Issues a Recall for Zantac
As the months went on and the FDA continued with its investigation, it later discovered with the help of third-party laboratories that the levels of NDMA continually increased in ranitidine when it was stored at normal conditions and significantly increased when it was stored at higher temperatures. Older products also had greater levels of NDMA. Because the levels drew concern as anyone who ingests high levels of NDMA is more at risk of developing cancer, the FDA eventually issued a request that all manufacturers of ranitidine products pull them from the market.
Canada Issues Recall for Zantac and Other Ranitidine Products
Around the same time that the FDA began conducting investigations into Zantac and other generic forms of ranitidine, Health Canada requested that companies cease ranitidine distributions while it assessed the chemical NDMA. It was also during this time that some product recalls were issued. Over the course of the next few months, Health Canada began issuing additional recalls for certain products, including Zantac.
Hong Kong and Australia Join U.S. and Canada by Issuing Recalls for Zantac
On September 29, 2019, the Government of the Hong Kong Special Administrative Region issued a statement acknowledging that the Department of Health authorized a licensed drug wholesaler, GlaxoSmithKline, to recall all Zantac products from the market as a precaution after the chemical NDMA was discovered in the drug.
The Australian Government’s Department of Health Therapeutic Goods Administration (TGA) also began warning its citizens of the presence of NDMA in ranitidine products. Although warnings were given in 2019, it wasn’t until 2020 when the TGA suspended all ranitidine products from being registered.
In addition to the U.S., Canada, Hong Kong, and Australia, there may also be other countries where Zantac has been recalled.
The Reason Why Zantac Has Been Recalled in Various Countries
As we previously mentioned, Zantac and all other ranitidine products contain NDMA. NDMA, when exposed to high amounts, can raise a person’s chances of developing cancer. Because the FDA determined through various investigations that the levels of NDMA present in ranitidine products increase over time and when the drug is stored in regular and high temperatures, the U.S. decided to recall Zantac, and other countries followed suit.
The Issue with NDMA
Although low levels of NDMA have been found in water and foods, it is classified as a B2 probable human carcinogen, according to the United States Environmental Protection Agency (EPA), which means if you are exposed to higher-than-normal levels, you could potentially develop cancer. In addition, if you were to ingest NDMA in high levels such as those present in certain ranitidine products, you could suffer liver damage, and you might experience the following symptoms:
- Increase in body temperature
- Feelings of nausea
- Abnormally high bilirubin levels (i.e., jaundice)
- Throwing up
- Stomach cramping
- Swollen liver
- Your liver, kidneys, and lungs may begin to malfunction
- Feelings of dizziness
What To Do if You Developed Cancer After Taking Zantac
Because Zantac, both prescription and over the counter, has been linked to cancer, many lawsuits have been filed against the makers of Zantac as consumers presumed the medicine they were taking was safe. Therefore, if you took Zantac at any point while it was available for purchase and you developed cancer or suffered adverse effects from it, you may have a valid case against Sanofi, the manufacturer of Zantac. When a manufacturer creates medication and fails to warn consumers of the dangers associated with taking it, it can be held financially liable if the product causes anyone harm.
If you would like to find out if you have a valid case against the makers of Zantac that may entitle you to recover compensation, contact Chalik & Chalik Injury Lawyers today at (855) 529-0269. Our legal team would be happy to provide you with a case assessment that would determine whether you have the grounds to sue for financial relief.