All Zantac has been recalled. The Food and Drug Administration (FDA) has requested the removal of all ranitidine drugs, including prescription and over-the-counter versions of the drugs. Better known as “Zantac,” this drug is a histamine-2 blocker that reduces stomach acid to treat heartburn and indigestion. It also helps to treat gastroesophageal reflux disease (GERD) and prevents stomach ulcers.
Regulators are requesting the removal of these medications out of fear for patient safety. Here is the essential information you need to know about the latest recall.
Why the FDA Is Requesting Removal of Zantac
The FDA began its investigation into the safety of Zantac after independent laboratory testing found that it could contain a substance considered a probable carcinogen. The independent laboratory testing concluded that there was an unacceptable level of this substance, called N-Nitrosodimethylamine (NDMA), in the product. NDMA was once used to create rocket fuel, but it is no longer used for this purpose because air, water, and soil samples contained high levels of the substance when it was used in this manner, according to the Centers for Disease Control and Prevention.
FDA representatives are concerned about the safety of the product because levels of this cancer-causing substance can increase over time while the product is being stored. Peak levels occur when the product is stored above room temperature. While distributors send this product to various drugstores, supermarkets and other locations, the product could be kept at above room temperature levels, which can make the product unsafe to consumers to use after it reaches its destination.
Potential Dangers of NDMA
The World Health Organization (WHO) classifies NDMA as a probable human carcinogen, meaning that the substance may cause cancer. WHO acknowledges that humans may be subjected to NDMA through drinking water. This form of exposure is associated with relatively low levels that do not correlate to higher cancer risks. However, NDMA can also be formed due to several industrial processes.
Some pesticides have this substance in them. When a person is exposed to high doses of NDMA over a prolonged period of time, he or she may develop cancer, according to a publication by Harvard Health Publishing.
History of the Zantac Recall
The FDA released the first announcement regarding the potential danger surrounding Zantac and other ranitidine products in September 2019. This spurred some manufacturers to voluntarily recall their products. Walgreens, CVS, and other drugstores followed suit shortly thereafter, removing the products from their stores.
On January 8, 2020, the FDA alerted the public and healthcare professionals to voluntary recalls by APPCO Pharma LLC of its prescription ranitidine capsules and Northwind Pharmaceuticals’ recall of its 150 mg and 300 mg prescription ranitidine tablets. American Health Packaging also voluntarily recalled its 150 mg ranitidine tablets by February 27, 2020. By this point, the FDA had advised companies to recall their ranitidine products if their internal testing showed NDMA above 96 nanograms per day.
On April 1, 2020, the FDA requested manufacturers to withdraw all ranitidine drugs from the market due to the NDMA threat.
What Manufacturers Are Doing in Response to the Request for Recall
The FDA has sent letters to all manufacturers of the drug, requesting that they withdraw all prescription and over-the-counter versions of Zantac immediately. The product will not be available to purchase for new or existing prescriptions or over-the-counter purchase in the United States.
What to Do If You Are Taking Zantac
The FDA recommends that consumers who are using the over-the-counter version of Zantac stop taking the medication immediately and dispose of any remaining liquids or tablets. They may switch to other available over-the-counter medications.
If you are taking the prescription version of the drug, the FDA recommends consulting with your doctor about other available treatment options before stopping your regimen.
The FDA has not found NDMA in similar products, including:
The FDA recommends using the packaging directions on how to safely dispose of unused medications.
Additionally, the FDA recommends that you report any adverse reactions that you have to the drug through the FDA”s MedWatch Adverse Event Reporting program by completing the necessary form and reporting the adverse event online.
We Can Help You Hold the Manufacturer Liable If You Suffered Harm
While all Zantac has been recalled, many people were still put at risk. If you have been harmed after taking Zantac or another medication, it is important that you discuss your legal rights with a lawyer. At Pintas & Mullins Law Firm, we often take on difficult cases to ensure that our clients are not further harmed by injuries they suffered due to no fault of their own. We work hard to get the defendant to pay for your treatment and other damages our clients have suffered.
We can discuss whether you have a viable claim during a free and confidential consultation. Call us at (800) 794-0444 so we can explain how we can help. We work on a contingency fee basis, so you will not be charged any attorney fees unless your claim is successful.