What You Should Know About The FDA Recall of Zantac

The Food and Drug Administration (FDA) continues to announce recalls of the popular heartburn medication Zantac and its generic formulation ranitidine due to contamination with the known carcinogen N-Nitrosodimethylamine (NDMA). The latest announcements of five additional Zantac and ranitidine recalls come a month after the agency announced initial recalls by Sandoz and Apotex and alerted the public that NDMA had been found in samples of ranitidine. These recalls include both prescription and over-the-counter Zantac.

Do I Have A Case?

Zantac has been on the market for over thirty years and millions of people have taken these medications. For anyone currently taking these drugs, you should immediately contact your doctor to discuss your options.

Zantac Recall Summary

Precision Dose Ranitidine Recall

On November 19, 2019, repackaging company Precision Dose Inc. voluntarily recalled 5 lots of Ranitidine Oral Solution–USP 150mg/ 10mL from the market. The ranitidine product is being recalled due to potential NDMA presence above the standards approved by the Food and Drug Administration.

The recall was initiated after manufacturer Amneal Pharmaceuticals, LLC) issued a voluntary recall which included lots repackaged by Precision Dose Inc.

Golden State Ranitidine Recall

On November 15, 2019, repackaging company Golden State Medical Supply, Incorporated (GSMS, Inc.) voluntarily recalled all quantities and lots of Ranitidine HCl 150mg and 300mg capsules due to the potential presence of NDMA above levels approved by the Food and Drug Administration.

The voluntary recall comes after GSMS, Inc received a recall notice from manufacturer Novitium on October 25, 2019 and initially recalled 7 lots of Ranitidine HCl 150mg and 12 lots of Ranitidine HCl 300mg capsules on November 6, 2019.

American Health Ranitidine Recall

On November 8, 2019, American Health Packaging voluntarily recalled 8 lots of Ranitidine Syrup (Ranitidine Oral Solution USP) 150mg/10mL Liquid Unit Dose Cups from the consumer market due to an “unexpected impurity” of NDMA detected in the finished products at levels deemed unsafe by the Food and Drug Administration.

The recall comes in response to manufacturer Lannett Company, Inc.’s voluntary recall of ranitidine products which included affected lots that were repackaged by American Health Packaging.

Amneal Ranitidine Recall

On November 8, 2019, Amneal Pharmaceuticals, LLC voluntarily recalled Ranitidine Tablets, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL that were distributed directly to wholesalers, distributors, retailers, and re-packagers due to potential NDMA levels deemed unacceptable by Food and Drug Administration standards.

Lannett Ranitidine Recall

On October 28, 2019 the FDA announced that Lannett Company, Inc. recalled all lots of its prescription ranitidine syrup. The recall includes Lannett’s ranitidine oral solution prescribed in 15mg/mL doses due to the confirmed presence of NDMA.

Novitium Pharma Ranitidine Recall

On October 25, 2019, the FDA confirmed that Novitium Pharma LLC recalled all lots of its over-the-counter Ranitidine Hydrochloride capsules in the United States. Novitium’s ranitidine recall includes all lots of 150 mg and 300 mg dosages sold in 30, 60, 100, and 500 count bottles. The FDA announcement states that the recall was due to potential unsafe levels of NDMA found in the capsules.

Perrigo Ranitidine Recall

On October 23, 2019, the FDA announced that Perrigo Company plc issued a worldwide recall of all lots of its over-the-counter ranitidine products. The announcement states that Perrigo halted shipments of its ranitidine products on October 8 due to the possible presence of NDMA. The Perrigo recall includes many popular ranitidine products, including the Publix over-the-counter store brand.

Dr. Reddy’s Ranitidine Recall

On October 23, 2019, the FDA announced that Dr. Reddy’s Laboratories, LTD. issued a voluntary recall of all lots of its ranitidine products – both prescription and over-the-counter – sold in the United States on October 1. This recall includes lots of ranitidine sold under store brand names at Walgreens, Target, Walmart, Kroger, and CVS. The ranitidine recall was initiated after product testing confirmed unsafe levels of NDMA. For a full list of products recalled under the Dr. Reddy’s ranitidine recall, visit the FDA recall page.

zantac-pill-containersSanofi Zantac OTC Recall

The FDA also confirmed on October 23, 2019 that Sanofi recalled all lots of its Zantac OTC (over-the-counter) medications sold in the United States and Canada on October 18. The company cited “inconsistencies in preliminary test results of the active ingredient used in the U.S. and Canadian products” as the reason for the recall. The Sanofi Zantac OTC recall includes all lots of Zantac 150, Zantac 150 Cool Mint, and Zantac 75.

Apotex Ranitidine Recall

On September 25, 2019, the FDA announced that Apotex Corp. voluntarily recalled its over-the-counter Ranitidine Hydrochloride tablets on a precautionary basis due to concerns of NDMA contamination. The Apotex ranitidine recall applied to 75 mg and 150 mg tablets sold under store brand names at Rite Aid, Walmart, and Walgreens pharmacies.

Sandoz Ranitidine Recall

On September 23, 2019, the FDA announced that Sandoz Inc. recalled all lots of its Ranitidine Hydrochloride capsules sold over-the-counter in the United States due to confirmed NDMA contamination. Sandoz is a subsidiary of the Swiss pharmaceutical conglomerate Novartis. The Sandoz ranitidine recall applies to 14 lots of Ranitidine 150 mg and 300 mg capsules sold in 30, 60, and 500 count bottles.

What Is Zantac?

Zantac is a medication that limits the production of stomach acid and belongs to a class of medications known as H2 blockers. It is sold as a generic under the name of its active ingredient, ranitidine. Zantac is sold over-the-counter to treat heartburn and acid indigestion, and prescribed for the treatment of duodenal and gastric ulcers, gastroesophageal reflux disease, and certain stomach and esophagus conditions.

What Is NDMA?

NDMA is classified as a probable human carcinogen that can form as a byproduct of industrial processes or, as in Zantac, from a reaction with the body. The chemical can be found in small quantities in drinking water but in levels that are considered generally harmless. The NDMA found in the recalled Zantac and ranitidine products is above levels considered safe by the FDA. NDMA had previously been found in the blood pressure medication Valsartan, which prompted a string of product recalls starting in July 2018.

NDMA exposure in Zantac and ranitidine has been linked to digestive system cancers such as:

  • Stomach cancer
  • Intestinal cancer (both of the small and large intestines)
  • Esophageal cancer
  • Prostate cancer
  • Pancreatic cancer
  • Leukemia
  • Non-Hodgkin’s Lymphoma
  • Multiple Myeloma
  • Bladder cancer
  • Stomach cancer
  • Colorectal Cancer
  • Liver Cancer
  • Kidney Cancer

Additionally, in babies born to mothers who took Zantac consistently throughout their pregnancies, NDMA has been linked to cancers, including brain cancers, in young children.

How We Can Help

GoldenbergLaw is currently investigating cases where an individual has taken Zantac or ranitidine and been diagnosed with one of the cancers listed above. Contact our Minnesota cancer attorneys today for a free consultation or call 612-436-5026. We have over 30 years of experience fighting negligent drug companies and have national leadership in NDMA contamination cases, let us deliver the Gold standard you deserve.

Litigation Update: Time to Round Up Roundup?

The link between the popular weed killer Roundup and cancer became public in 2015 when the International Agency for Research on Cancer (IARC)—the agency devoted to cancer research within the World Health Organization—released a report exposing the connection between Roundup’s active ingredient glyphosate and cancer.

Since the IARC released this report, thousands of Roundup users have tied their diagnoses of Non-Hodgkin’s Lymphoma to Roundup exposure and taken legal action.

What Is Happening With The Roundup Litigation?

As of November 2019, analysts project that there are more than 45,000 Roundup plaintiffs in the United States. That number stands in sharp contrast to Bayer AG’S July 2019 estimate of 18,400.

Bayer AG has lost all three Roundup lawsuits it has taken to trial, with each jury finding that the plaintiffs’ exposure to glyphosate caused their diagnoses of Non-Hodgkin’s Lymphoma. Several additional trials that were scheduled for fall 2019 have been postponed to early 2020.

What Have The Roundup Trials Revealed?

In addition to juries finding that glyphosate can cause cancer, the Roundup trials have revealed questionable business practices by Monsanto—the original manufacturer of Roundup. Monsanto glyphosate-structure-chalkboardwas purchased by Bayer AG in 2018.

Documents produced at the trials have exposed that Monsanto engaged in “ghostwriting” research about glyphosate.  In other words, the company paid prominent scientists, researchers, and journalists to put their names on favorable research about glyphosate that was actually produced by Monsanto employees. Additionally, Monsanto allegedly lobbied for help from the Environmental Protection Agency (EPA) to hide a negative study of glyphosate that was released by the Department of Health and Human Services.

Bayer AG’s Legal Response

Bayer AG inherited massive litigation expenses with their acquisition of Monsanto for $63 billion in 2018. Since then, the Roundup crisis has already cost Bayer AG more than $30 billion in market value. Analysts have estimated that settling all of the U.S. Roundup lawsuits could cost anywhere between $2.5 billion to $20 billion. The company announced in July 2019 that it had begun mediation talks with Ken Feinburg to attempt to reach a settlement.

What Is Bayer Saying About Roundup Now?

Bayer AG continues to assert that Roundup is safe and that glyphosate is not carcinogenic. Therefore, the company has never considered pulling Roundup off the market despite the mounting allegations, research, and trial verdicts questioning its safety for consumers.

Bayer AG has been steadfast in refusing to add a warning label to Roundup products, issue a recall, or any outright discontinuance of the products containing glyphosate. However, that strategy comes with legal consequences. As long as the product continues to be sold without a warning label, the company is exposed to lawsuits linking ongoing Roundup use to future cancer diagnoses.

Despite refusing to remove Roundup from the market or add a warning label, Bayer AG announced in June 2019 that it was researching a glyphosate alternative at a cost of $5.6 billion.

What Are The Symptoms of Non-Hodgkin’s Lymphoma?  

Symptoms of Non-Hodgkin’s Lymphoma – the illness allegedly caused by use of Roundup exposure – include:

  • Painless, swollen lymph nodes in your neck, armpits, or groin;
  • Abdominal pain or swelling;
  • Chest pain, coughing or trouble breathing;
  • Persistent fatigue;
  • Fever;
  • Night sweats;
  • Unexplained weight loss 

What Should I Do Now?

If you or a loved one has been diagnosed with a form of Non-Hodgkin’s Lymphoma after Roundup use and/or exposure, please reach out to GoldenbergLaw’s Minnesota Roundup Cancer Attorneys. We will guide you through the legal process and fight to get you the compensation needed to help get your life back on track. Let us deliver the Gold standard advocacy you deserve.

Dangers of Adolescent E-Cigarette Use on Brain Development

E-cigarettes are the most commonly used form of tobacco among adolescents in the United States. The National Institute on Drug Abuse reports that e-cigarettes have become so popular among young people due to their “easy availability, alluring advertisement, e-liquid flavors, and the belief that they are safer than cigarettes.” Along with exposing users to serious injuries such as heart attacks, strokes, and seizures, frequent use of highly addictive e-cigarettes like JUUL can permanently alter the developing brain.

Do I Have A Case?

How Common is Adolescent E-Cigarette Use?

According to the National Safety Council’s report based on the University of Michigan’s annual survey results in January 2019, the percentage of teenagers who reported vaping within the last twelve months has increased to record levels.

addiction-brain-smoke-cloudThe most drastic increase within the last year occurred with high school seniors, 37% of whom indicated that they had vaped in 2018. That represented a 9% increase since 2017. Equally startling statistics were reported regarding sophomores in high school; 32.3% reported vaping in 2018 compared to 23.9% in 2017. Additionally, the percentage of ninth graders who said they have vaped at least once in their lifetime rose from 35.8% in 2017 to 42.5% in 2018.

In a December 2018 press conference, U.S. Surgeon General Jerome Adams declared e-cigarette use among adolescents an “epidemic.”

What is the Impact of E-Cigarette Use on the Brain?

Until the age of 25, the human brain has not fully developed. As a result, during the adolescent years the part of the brain that is responsible for decision making and impulse control—the pre-frontal cortex—has not reached maturity. Therefore, injuries that occur within the brain during this time period result in higher risk of permanent damage.

Nicotine addiction is a common and frightening result of e-cigarette use. When the nicotine found in the e-cigarettes’ “e-liquids” is absorbed by the lungs and into the bloodstream, it stimulates the adrenal glands to release the adrenaline hormone. That release of adrenaline triggers the central nervous system to increase blood pressure, breathing, and heart rate.

Nicotine also activates the brain’s reward circuits by increasing the production of dopamine. The chemical dopamine reinforces nicotine consumption due to the rush of pleasure that accompanies the dopamine release. In order to continue the dopamine production and consequent chemical pleasure, nicotine consumption increases and may lead to nicotine addiction.

The developing brain creates more synapses—the pathways formed when new memories are made or skills are practiced—than the developed brain. As a result, when more synapses are created pertaining to the use of e-cigarettes and the corresponding exposure to nicotine, the likelihood of nicotine addiction increases.

In addition to the elevated risk of addiction from exposing the developing brain to nicotine, there is an increased risk of mood disorders, lessened attention span and learning capacity, and permanently decreased impulse control.

What Should I Do if My Loved One has been Harmed by E-Cigarettes? 

If you or a loved one has developed a nicotine addiction or suffered a heart attack, stroke, or lung injury after the use of a JUUL vaping device, contact the Minneapolis E-cigarette attorneys at GoldenbergLaw. With over 30 years of experience holding corporate wrongdoers accountable, we deliver the Gold standard advocacy you deserve.