Zantac (ranitidine) is taken for conditions including heartburn, acid indigestion, sour stomach, gastroesophageal reflux disease (GERD), ulcers, and erosive esophagitis, among others. The FDA has recently announced the recall of Zantac and its generic formulation ranitidine due to contamination with the probable human carcinogen N-Nitrosodimethylamine (NDMA).
If you or a loved one has been diagnosed with cancer after taking Zantac or ranitidine, contact one of our Minnesota Cancer Lawyers today. Our team has over 30 years of complex litigation experience and will deliver the Gold standard advocacy you deserve.
Case Quick Facts
In the Citizens’ Petition, Valisure explains that the ranitidine molecule is very unstable. As a result of the way the human body breaks down the medication, NDMA is formed inside the human body.
In January 2020, Emery Pharma filed a Citizen Petition with the FDA after it found Zantac and ranitidine products produced NDMA when stored over time or when exposed to temperatures higher than room temperature. Emery’s petition also requested the FDA recall all Zantac and ranitidine products.
Between September 2019 and April 2020, the FDA announced 16 different recalls of Zantac and ranitidine products.
On April 1, 2020, the FDA recommended the recall of all Zantac and ranitidine products sold in the United States.
What happens when you are exposed to NDMA?
NDMA is classified as a probable human carcinogen and as a known animal carcinogen. Therefore, exposure over prolonged periods of time or in high and concentrated doses to NDMA can cause a variety of types of cancer.
NDMA has been linked to the following types of cancers in medical studies:
- Bladder Cancer
- Colorectal / Intestinal Cancer
- Esophageal Cancer
- Gastric Cancer
- Liver Cancer
- Lung Cancer
- Pancreatic Cancer
- Prostate Cancer
Zantac was first approved in 1983 and was manufactured by Glaxo Holdings, Ltd. (now GlaxoSmithKline). In 2004, Pfizer received FDA approval to sell over-the-counter Zantac, and rights were subsequently transferred from Pfizer to Johnson & Johnson, Boehringer Ingelheim Pharmaceuticals, and to Sanofi. Sanofi sold branded, over-the-counter Zantac until it recalled the product in October 2019. Other types of branded Zantac (the injectable solution) have been made by Teligent.
Generic versions of Zantac (ranitidine) have been manufactured and sold within the United States for years by a number of different manufacturers, including Novitium Pharma, Mylan, Sandoz, Ani Pharms, Inc., Apotex, Bedford, West-ward Pharms Int., Watson Labs, Ranbaxy, Contract Pharmacal, Sun Pharms, Industries Ltd., Heritage Pharma, Par Pharm, Wockhardt, Ltd., Dr. Reddy’s Labs, Ltd., Teva, Actavis Mid Atlantic, Perrigo, Pharm Assoc., Taro, Amneal Pharms NY, Glenmark Pharms, Inc., Breckenridge, Lannett Co., Inc., Anda Repository, Torrent, Aurobindo Pharma, Ltd., Hi Tech Pharma, Nostrum Labs, Inc., Zydus Pharms USA, Inc., Strides Pharma, Acic Pharms, Ajanta Pharma, ltd., Unique Farm Labs, Granules India Ltd., VKT Pharma PVT Ltd., and Appco Pharma, LLC.
GoldenbergLaw Can Help
GoldenbergLaw is currently investigating cases where an individual has taken Zantac or ranitidine and developed cancer. We have been litigating defective pharmaceutical cases for over thirty years and have the knowledge, experience and compassion you deserve.
Contact us today for a free consultation.
Partner Marlene Goldenberg Appointed to Zantac’s Litigation Plaintiff Steering Committee
In May 2020, Judge Robin L. Rosenberg from the U.S. District Court for the Southern District of Florida appointed 26 lawyers to spearhead the Zantac and Ranitidine litigation. GoldenbergLaw Partner Marlene Goldenberg was among the lawyers appointed to the Plaintiff Steering Committee (PSC) to help lead the litigation.
Zantac Litigation Update
In the Southern District of Florida, under the supervision of Judge Rosenberg, the Zantac Multi-District Litigation (MDL) continues gathering census data on the multitude of Zantac plaintiffs. As the MDL leadership receives this information, they are running analytics on the data to better understand the size and scope of the client population, and are using this data to chart the best course forward for this litigation. Discovery is also well underway – nearly every defendant involved in the litigation has begun to submit large volumes of documents to plaintiff’s leadership and plaintiffs’ attorneys have begun combing through these documents to investigate the potential liability of the manufacturers of Zantac.
A Personal Message From Senior Partner Stuart Goldenberg
We often hear the phrase that “cancer does not discriminate.” However, we are now learning that defects in everyday products like Zantac could be contributing to the astronomical increase in cancer diagnoses in America. This news is devastating, and completely unacceptable. GoldenbergLaw has worked for many years to hold negligent manufacturers accountable for dangerous products. We have helped thousands of people obtain justice, and we are here for you now. We will help you with care and concern to understand your rights and choices. Please give us a chance to help you.
What is an MDL?
A multidistrict litigation (MDL) involves individual lawsuits that have been filed in federal courthouses throughout the country which are then consolidated and transferred to a single federal court for efficiency.
When MDLs are Used
Congress created MDLs to save time and money in addition to ensuring similar outcomes in lawsuits that involve a substantially large number of clients (sometimes thousands of individual lawsuits) and contain similar allegations. If the large number of cases are focused around similar allegations, the lawyers involved in the individual lawsuits may ask the Judicial Panel on Multidistrict Litigation to create an MDL for consolidation purposes. Although the cases are consolidated, each individual case still retains their individual attorney and their individual case will be decided based on that specific case’s facts.
How MDLs are Resolved
After the discovery process, where documents and other relevant information are exchanged between parties, the judge may select some of the individual lawsuits to proceed as “bellwether trials.” Bellwether trials are essentially test runs to see how juries respond to the arguments presented by each side. Although the result of a bellwether trial is only binding on the particular plaintiff whose case is being tried, bellwether trials help both parties determine how juries may rule on all of the cases. This may lead to reaching a global settlement. For example, if the defendant loses all of the bellwether trials, they may be more inclined to reach a global settlement as opposed to trying all of the cases in the MDL.
Zantac MDL Updates
The JPML assigned the Zantac MDL to the Southern District of Florida on February 6, 2020. The Zantac MDL will increase the speed of litigation for victims who suffer from cancer as a result of the recalled heartburn medication and its generic brand, Ranitidine. Given the popularity of the drug, many legal observers expect the Zantac MDL to be one of the largest MDLs in history.
If you or a loved one developed cancer after taking Zantac or ranitidine, contact GoldenbergLaw today for a complementary consultation. We have extensive experience in litigating contaminated drug cases and believe strongly in promoting safety through accountability.
Global Recall of Zantac and What It Means
On April 1, 2020, The Food and Drug Administration (FDA) requested the recall of all Zantac and Ranitidine products from the U.S. market due to contamination with the probable human carcinogen N-Nitrosodimethylamine (NDMA). In explaining its decision to request a global recall, the FDA acknowledged that the NDMA impurities found within the popular heartburn medications can increase to dangerous levels when products are stored over time or exposed to high temperatures. This recall followed 16 different FDA recalls of Zantac and ranitidine products since testing first discovered NDMA in the heartburn medications in September 2019.
This Zantac recall will affect 15 million Americans who take prescription strength Zantac and ranitidine products and millions more who take over-the-counter versions. Sandoz was the first company to issue a voluntary recall for generic ranitidine on September 24, 2019 and other generic manufacturers followed. However, Sanofi–the manufacturer of brand-name Zantac–did not issue a recall at that time. However, on October 18, 2019, Sanofi announced it was issuing a voluntary recall of brand-name Zantac OTC (the over-the-counter formula of the drug) for the entire U.S. and Canadian markets. By March 27, 2020, 15 companies had issued ranitidine recalls in the United States.
In addition to recalls in the U.S., Zantac and Ranitidine recalls have occurred worldwide – 43 other countries and jurisdictions have responded to the reports of NDMA contamination by issuing bans, recalls or warnings. These countries include Canada, Germany, France, Ireland, UK, Australia, New Zealand, Japan, Indonesia, Greece, South Korea, Taiwan, Italy, Norway and Namibia.
Government Investigations into Zantac
In June 2020, the U.S. Department of Justice (DOJ) for the Eastern District of Pennsylvania opened an investigation into the Zantac and Ranitidine NDMA contamination allegations. Zantac manufacturers Sanofi-Aventis US LLC (Sanofi) and GlaxoSmithKline LLC (GSK) have been implicated in the investigation. The investigation will focus on the claim that the manufacturers violated the False Claims Act by not disclosing information about the potential presence of the probable human carcinogen N-nitrosodimethylamine (NDMA) in their products.
Both Sanofi and GSK filed U.S. Securities and Exchange (SEC) Filings after the investigation was announced. Sanofi explained in their filing that the company was notified of the investigation on June 6, 2020 and the probe requested “information and documents with Sanofi, including applications and communications with the [U.S. Food and Drug Administration]” along with a civil investigative demand on June 18.
Additionally, in June 2020, New Mexico’s Attorney General Hector Balderas sued Sanofi and other generic manufacturers such as GSK. The case claimed that the companies had violated the state’s Unfair Practices Act, False Advertising Act, and public nuisance and negligence laws.
Scientific Studies Find NDMA Contamination in Zantac
The Valisure Testing
In September 2019, An independent study from the Valisure Online Pharmacy sought to understand how capable Ranitidine was of naturally producing NDMA. The testing by the laboratory simulated the conditions that Ranitidine is exposed to in the human stomach in order to determine how it would react. This was accomplished by mixing Ranitidine with the gastric fluid and sodium nitrites that stimulate the digestion process. After doing this, they discovered that when Ranitidine interacts with the gastric fluid and sodium nitrites found in the stomach, high amounts of NDMA were produced–approximately 304,500 nanograms (ng) of NDMA per tablet. This is a staggering amount of NDMA considering that the FDA-approved acceptable daily intake amount of NDMA is 96 ng per day. In September 2019, Valisure filed a Citizen Petition with the FDA regarding their findings and requested the agency recall the medication.
The Emery Pharma Testing
The independent laboratory Emery Pharma announced in January 2020 that it found elevated levels of NDMA in Zantac when the drug is exposed to heat.
The laboratory tested various samples of Ranitidine stored at different temperatures over different periods of time. Emery found that the samples stored for five days at 158 degrees Fahrenheit contained 142 nanograms of NDMA, contamination that is well over the FDA’s acceptable daily limit of 96 nanograms. Samples stored as low as 77 degrees Fahrenheit showed a gradual increase of NDMA formation, up to 25 nanograms over 12 days. Although this falls under the FDA’s acceptable daily levels of NDMA, it raises the possibility that levels could continue to rise over long periods of time at that temperature.
The key takeaway to these findings is that NDMA can be produced in Ranitidine products well after passing safety tests conducted at the manufacturer level. Therefore, although manufacturers may have deemed Zantac and other Ranitidine products safe for consumption, the medications could still produce well over the acceptable safe levels of NDMA when exposed to certain temperatures.
Zantac FDA Recall Timeline
- September 13, 2019: The FDA issues a statement alerting the public that some ranitidine medications were found to contain NDMA.
- September 24, 2019: The FDA announces that Sandoz, Inc. is recalling 14 lots of prescrtiption ranitidine capsules due to the confirmed detection of NDMA.
- September 25, 2019: The FDA announces that Apotex Corp. is recalling all lots of its 75 mg and 150 mg over-the-counter ranitidine tablets on a “precautionary basis” due to findings of NDMA in ranitidine medications. This recall includes many lots sold under store names at Rite Aid, Walmart, and Walgreens.
- October 2, 2019: The FDA asks manufacturers to use a Liquid Chromatography-High Resolution Mass Spectrometry (LC-HRMS) testing method for detecting NDMA in their ranitidine medications. The agency announces it will begin testing ranitidine oral medications along with other H2 blockers and proton-pump inhibitors for NDMA impurities.
- October 23, 2019: The FDA announces that Dr. Reddy’s Laboratories Ltd. is recalling all lots of its prescription and over-the-counter ranitidine medications due to confirmed NDMA contamination. This recall includes many lots sold under store names at Kroger, Walgreens, Walmart, CVS, and Target.
- October 23, 2019: The FDA announces that Sanofi is recalling all lots of its Zantac OTC products sold in the United States and Canada due to “inconsistencies” in test results conducted after NDMA contaminations were found by other manufacturers. This recall includes Zantac 150, Zantac 150 Cool Mint, and Zantac 75.
- October 23, 2019: The FDA announces that Perrigo Company plc is issuing a worldwide recall of all lots of its ranitidine medications due to the “possible presence” of NDMA impurities.
- October 25, 2019: The FDA announces that Novitium Pharma is recalling all lots of its Ranitidine Hydrochloride Capsules in the United States due to potential unsafe levels of NDMA. This recall includes prescription strength Ranitidine Hydrochloride 150 mg and 300 mg Capsules.
- October 25, 2019: The FDA announces that Lannett Company Inc. is recalling all lots of its Ranitidine Syrup due to confirmed unsafe levels of NDMA. This recall includes all prescription strength Ranitidine Hydrochloride Oral Solution.
- November 8, 2019: The FDA announces that Amneal Pharmaceuticals is recalling all lots of its Ranitidine 150 and 300 mg tablets and Ranitidine Syrup Oral Solution due to potential unsafe levels of NDMA.
- November 8, 2019: The FDA announces that American Health Packaging is recalling 8 lots of its Ranitidine Syrup Oral Solution due to confirmed NDMA impurities found in the finished product of the drugs.
- November 15, 2019: The FDA announces that Golden State Medical Supply is recalling all lots of its Ranitidine HCl 150mg and 300mg capsules due to potential unsafe levels of NDMA contamination.
- November 19, 2019: The FDA announces that Precision Dose is recalling 5 lots of Ranitidine Oral Solution due to potential contamination of NDMA at levels deemed unsafe for public consumption.
- December 17, 2019: The FDA announces that Glenmark Pharmaceuticals is voluntarily recalling all unexpired lots of its Ranitidine 150 mg and 300 mg tablets due to potential NDMA contamination.
- January 8, 2020: The FDA announces that Northwinds Pharmaceuticals is recalling all lots of prescription Ranitidine 150 mg and 300 mg it had repackaged and distributed in response to a similar recall at the manufacturer level.
- January 8, 2020: The FDA announces that Appco Pharma is recalling all lots of its prescription Ranitidine Hydrochloride capsules due to concerns of NDMA contamination.
- April 1, 2020: The FDA recommends the recall of all Zantac and ranitidine products sold in the United States.
Zantac Lawsuit FAQs
Do I Have A Zantac Case?
If you have taken Zantac or ranitidine and been diagnosed with cancer, you may have a case against the manufacturers. Contact GoldenbergLaw today for a free case evaluation.
Why Is Zantac Being Recalled?
Zantac and ranitidine are being recalled due to contamination with the probable human carcinogen NDMA. According to Valisure’s Citizen’s Petition, all types of Zantac and ranitidine are affected by the NDMA contamination. The problem is with the molecular structure of the drug, which is consistent across all types of both branded Zantac and generic ranitidine.
Is All Zantac Recalled?
Yes. On April, 1, 2020, the FDA requested the recall of all Zantac & ranitidine products from the U.S. market.
Should I Continue Taking Zantac?
The FDA recommends that patients who take prescription versions of Zantac and ranitidine should speak with their physicians before making any changes. The FDA further noted that consumers taking over-the-counter versions of Zantac or ranitidine should cease use of these products and safety dispose of any remaining medication.
What Is The FDA Doing About The Zantac Recall?
The FDA has recommended the removal of all Zantac and ranitidine products from the U.S. market. The FDA Zantac recall is the product of months of testing to determine whether the product was contaminated with the probable human carcinogen NDMA. On September 13, 2019, the FDA released a statement, indicating that “some ranitidine medicines” contain NDMA “at low levels.” FDA further indicated the agency would be examining levels and the possible risk to patients.
Since that time, Sandoz, Apotex Corporation (which also manufactured the Rite Aid, Walmart, and Walgreens brand tablets), Perrigo Company Plc, Novitium, Dr. Reddy’s (which also manufactured Sam’s Club, Kroger, Walgreens, Walmart, CVS, CDMA, HCA, Target, Thirty Madison, and GeriCare ranitidine products), Sanofi, and Lannett Company, Inc. have recalled some or all of their Zantac products. On April 1, 2020, the FDA recommended that all Zantac and ranitidine products be recalled.
Can I Still Take Zantac While I Am Pregnant?
Zantac and ranitidine products have been recalled from the U.S. market. Therefore we recommend speaking with your doctor about what course of action might be safest for you and your baby if you are currently taking Zantac or a ranitidine product.
Zantac has been classified as a Category B medication, meaning that it is safe for use during pregnancy. Specifically, a medication placed into Category B means that animal reproduction studies have failed to demonstrate a risk to the fetus, and there are no well-controlled studies in pregnant women. While this may sound a little frightening, there are very few medications in Category A, simply because it is exceptionally difficult to run studies on pregnant women due to ethical issues.
However, some studies have shown that NDMA can cross the placental barrier.
Why Are We Hearing So Much About NDMA In Medications?
NDMA and other related nitrosamines (such as NDEA and NMBA) were also discovered in other medications, including valsartan and losartan somewhat recently. While the reason for the contamination in those drugs relates to the manufacturing process, as opposed to the molecular makeup of the drug, the risks of NDMA exposure can result in many of the same types of cancers and other complications.
What Compensation Am I Entitled To In A Zantac Lawsuit?
If you have been diagnosed with cancer after using Zantac or ranitidine, you may be entitled to compensation for your injuries. Contact GoldenbergLaw for a free consultation and to learn more about the Zantac litigation.
Why Choose GoldenbergLaw?
When it comes to Zantac lawsuits, our Zantac Cancer litigation team is ready to help you discuss your options. We have over thirty years of experience representing cancer victims, let us deliver the Gold standard advocacy you deserve.