Zantac (brand name for ranitidine) is a popular heartburn drug that was recently recalled by its primary manufacturer, Sanofi, after discovering the drug can produce toxic amounts of a cancerous chemical in the body known as NDMA.
The U.S. Food and Drug Administration (FDA) released a statement on this concerning link between ranitidine (Zantac) products and various types of cancer on September 13, 2019.
Since this initial announcement, 14 pharmaceutical companies have issued voluntary recalls of ranitidine products, including Dr. Reddy’s Laboratories—which distributes Walgreens, CVS Health, and Kroger-brand ranitidine products.
Common brand names for over-the-counter (OTC) ranitidine products include:
- Zantac (Zantac 75, Zantac 150, Zantac 150 Cool Mint)
- Acid Reducer
- Acid Control
- Heartburn Relief
The FDA has not issued any mandatory recalls of ranitidine products at this time, despite significant evidence pointing towards an established link between Zantac use and various cancers.
Thousands of people across the United States have started taking legal action against top Zantac drugmakers for their role in manufacturing, marketing, and selling potentially cancerous drugs to the public without properly informing healthcare providers of this danger.
If you or a loved one has been diagnosed with cancer after taking ranitidine (Zantac), the attorneys of Florin|Roebig can help you determine if you are eligible to join others in suing Zantac drugmakers for their negligence.
List Of Zantac (Ranitidine) Product Recalls
At this time, only certain lots of Zantac and ranitidine products have been pulled from the U.S. market. These recalls have been issued on a voluntary basis by over a dozen pharmaceutical companies, as well as some pharmacies, drugstores, and big-box stores.
Sandoz. Inc was the first drugmaker to issue a voluntary recall of their ranitidine products, 10 days after the initial FDA announcement which reported the potential link between ranitidine and cancer.
The creator of brand-name Zantac products, Sanofi, initially delayed issuing a voluntary recall, stating that the NDMA levels within their drugs “barely exceed amounts found in common foods,” according to a statement given to the New York Times. However, they too issued a recall for their Zantac products on October 23, 2019, more than a month after the FDA released their initial statement.
The FDA lists all drug recalls—mandatory and voluntary— in which public notification has been issued on their website. As of February 2020,14 pharmaceutical companies have issued recalls for their ranitidine and Zantac products.
Pharmaceutical companies which have issued Zantac and ranitidine product recalls include:
- Sandoz Inc. (ranitidine hydrochloride capsules)—09/23/2019
- Apotex Corp (ranitidine 75mg and 150mg tablets)—09/25/2019
- Perrigo Company plc (all pack sizes ranitidine)—10/23/2019
- Sanofi (Zantac 150, Zantac 150 Cool Mint, Zantac 75)—10/23/2019
- Dr. Reddy’s, Kroger, Walgreens, and others (ranitidine tablets and capsules)—10/23/2019
- Novitium Pharma (ranitidine 150mg and 300mg capsules)—10/25/2019
- Lannett Company, Inc (ranitidine oral solution 15mg/mL)—10/25/2019
- Aurobindo Pharma (ranitidine)—11/06/2019
- American Health Packaging (AHP) (ranitidine liquid unit dose cups)—11/08/2019
- GSMS (ranitidine HCl 150mg and 300mg capsules)—11/15/2019
- Precision Dose (ranitidine syrup, 10 mg/mL)—11/19/2019
- Amneal Pharmaceuticals (ranitidine tablets 150mg and 300mg, and syrup 15mg/mL)—11/22/2019
- Glenmark Pharmaceuticals (ranitidine 150mg and 300mg tablets)—12/17/2019
- Appco Pharma (ranitidine 150mg and 300mg tablets)—01/07/2020
Several of the listed pharmaceutical companies are currently being sued by individuals across the U.S. for the drugmakers’ failure to inform the government and the public about the carcinogenic effects of their drugs.
Why Zantac And Ranitidine Products Are Being Recalled
The primary reason several Zantac and ranitidine products have been recalled in recent months is due to the discovery of a link between these products and certain types of cancer. This discovery was made during a routine testing of ranitidine products by the online pharmacy, Valisure, early last year.
These test results showed toxic levels of the chemical, NDMA, in ranitidine products—reaching upwards of 31,000 times higher than FDA-recommended daily intake in each drug tablet:
- Maximum FDA-recommended daily intake: 96 nanograms
- Amount of NDMA found in ranitidine products: 300,000 nanograms
N-Nitrosodimethylamine (NDMA) is classified as a probable carcinogen by the U.S. Environmental Protection Agency and other federal agencies, meaning it can cause cancer with excessive and prolonged exposure. According to Valisure, the reason for the dangerously high concentrations of NDMA in ranitidine is due to how the drug metabolizes in the body.
When taken, the chemicals within Zantac drugs can produce toxic amounts of NDMA, which has been linked to liver disease, kidney damage, and several types of cancer.
The number of people that are likely to be affected by these potentially cancerous effects after taking Zantac (ranitidine) products is still unknown. Researchers at Harvard Medical School have stated that NDMA “may cause cancer only after exposure to high doses over a long period of time.”
Despite this, several lawsuits have already been filed against ranitidine manufacturers by individuals who have either been diagnosed with cancer after taking ranitidine or who have lost a loved one to cancer after they had taken ranitidine.
Mandatory Vs. Voluntary Zantac Recalls
Although many Zantac drugmakers have made the informed decision to recall products containing ranitidine voluntarily, a distinction can be made between these recalls and a mandatory recall.
In the United States, mandatory recalls outside the FDA are rare, in part because they can be costly and resource-intensive to execute. Voluntary drug recalls from pharmaceutical companies are voluntary actions that may be requested by the FDA, but are not required. Voluntary recalls may be made for several reasons, but are largely concerned with consumer safety.
Common reasons for drug recalls include:
- discovery of a previously unknown drug interaction
- insufficient or defective warning labels
- manufacturing errors
- discovery of other health risks associated with use of the drug
The purpose of issuing a voluntary recall is to pull the defective drug from the market to correct the issue or otherwise reassess the discovered defect.
At this time, the FDA has not issued a mandatory recall of all ranitidine and Zantac products in the United States.
This poses a stark contrast to countries such as Canada, which have not only issued mandatory recalls on all ranitidine products, but have also banned all sales of ranitidine products. Globally, numerous countries have followed suit.
Classifications For Drug Recalls
Drug recalls are further classified by the FDA according to the scope of the drug defect and the severity of the potential dangers posed by the drug defect.
Classifications for U.S. Food and Drug Administration drug recalls include:
- Class I: Dangerous or defective product that could cause death or serious effects on health
- Class II: Defective product that poses a slight risk of a serious threat, or may cause temporary health problems
- Class III: Defective product that violates FDA labeling or manufacturing laws but is unlikely to pose health problems
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What To Do If You’ve Taken Zantac Or Ranitidine
If you or a loved one has taken or is currently taking ranitidine (Zantac) for a health condition, do not stop taking it without first consulting your doctor.
Although the FDA has issued statements offering suggestions for safe alternatives to ranitidine products, the federal agency has not yet recommended that people who are taking ranitidine stop taking the drug. If you’ve taken Zantac and are concerned about your cancer risk, consider the following steps:
Contact Your Physician
Speaking to your doctor is the first step to take if you are concerned about whether you are at risk for cancer due to Zantac, or to determine if your cancer was caused by the use of Zantac.
A doctor who knows your medical history will be able to offer personalized guidance on your drug regimen based on the nature of your condition, available alternatives, and health status.
Contact A Personal Injury Attorney
If you believe you or a loved one’s cancer diagnosis may be tied to the use of ranitidine (Zantac) products, you may be eligible to join others in suing Zantac drugmakers.
By contacting a Zantac attorney, you can determine your eligibility for joining a class action lawsuit or filing an individual lawsuit for personal damages wrought by your use of cancerous Zantac products.
An attorney with experience handling dangerous drug lawsuits can:
- obtain your medical history to use as evidence for your case
- consult legal, medical, and pharmaceutical experts
- represent your interests in seeking compensation from liable drug manufacturers
- explain the legal process and settlement expectations based on the nature of your case
- fight for a fair settlement on your behalf
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Zantac Lawsuits: How To Take Legal Action Against Zantac Manufacturers
When it comes to joining dangerous drug lawsuits, time is of the essence. The statute of limitations (deadline for taking legal action) in personal injury and product liability cases can vary by state and may restrict how long you have to begin filing a lawsuit against Zantac drugmakers.
Since news first broke of the cancerous NDMA in Zantac products in September 2019, several multidistrict and class action lawsuits have been filed against primary manufacturers of ranitidine products across the United States.
Defendants named in recent lawsuits include the creator of brand-name Zantac products, Sanofi, as well as Boehringer Ingelheim, Pfizer, GlaxoSmithKline, and more.
These plaintiffs are suing Zantac drugmakers on account of their failure to:
- lawfully warn the government, healthcare providers, and the public about the potential dangers of taking Zantac
- disclose how the ingredients within ranitidine can produce excessive (cancerous) amounts of NDMA in the body when taken
An investigation is still underway into whether these drug manufacturers knew of the dangers of taking ranitidine before this most recent discovery and whether they intentionally withheld this information from the public.
In personal injury cases, the intent of the defendants can impact the types of damages awarded to plaintiffs. It may also affect the consequences these drugmakers are required to face if it is determined that their negligence posed a significant danger to the global public.
Most individuals who have filed lawsuits against Zantac drugmakers have either been diagnosed with cancer after taking ranitidine products, or are suing on behalf of a loved one who developed cancer and passed away after using ranitidine.
However, even people who have not developed cancer may still be eligible to sue Zantac on the basis of product liability, in order to recover money spent on the drugs.
Find Help Filing A Zantac (Ranitidine) Lawsuit
If you or a loved one has suffered negative health effects after taking ranitidine (Zantac), you may be able to seek compensation through filing an individual or class action lawsuit.
Are you ready to join others in suing Zantac drug makers for their cancerous products? The award-winning attorneys of Florin|Roebig can help. Our attorneys can determine your most appropriate option for legal recourse based on the details of your case.
Your story matters. Don’t wait to begin taking action against Zantac drugmakers to seek justice for yourself or a loved one. Contact Florin|Roebig today to schedule a free case evaluation with one of our highly skilled Zantac attorneys.