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After Numerous Recalls, the FDA Requests Removal of All Ranitidine From the Market

Posted on 5th October, 2020

by Legal Staff

It is the responsibility of the U.S. Food and Drug Administration to ensure that medicines available to Americans are safe and effective. To that end, the Federal agency of the Department of Health and Human Services investigates the potential risks and dangers of prescription drugs.

Companies began recalling certain lots of the popular heartburn drug Zantac and its generic version after they found traces of NDMA, a known carcinogen.

On April 1, 2020, due to the risks associated with NDMA impurities, the FDA issued an immediate market withdrawal request for all manufacturers, which means the popular medication used to treat symptoms of acid reflux or heartburn will no longer be available for prescription or over-the-counter use in the U.S.

The Timeline of the Events Involving NDMA Contamination in Ranitidine Products

  • June 2019: The online pharmacy Valisure discovers NDMA in every lot of ranitidine it tested and petitions the FDA to recall and suspend sales of ranitidine from the U.S. market. The pharmacy detected over 3,000,000 nanograms of NDMA in each ranitidine tablet, while the acceptable daily limit is 96 nanograms.
  • August 2019: The FDA conducts laboratory tests and detected NDMA in limited ranitidine samples at low levels.
  • September 2019: The FDA advises consumers, patients, and health care professionals to consider alternative over the counter and prescription treatments but did not issue a recall, saying that they could not determine how ranitidine becomes contaminated with NDMA.
  • September 24, 2019: Manufacturer Sandoz, a Novartis division, issues the first voluntary recall of its 150 mg and 300 mg ranitidine capsules.
  • September 28 to October 2, 2019: The pharmacy chains Walgreens, CVS, Rite-Aid, and Walmart Inc. suspend all sales of Zantac and other over-the-counter ranitidine medications.
  • October 2019: The FDA releases a second liquid chromatography-mass spectrometry (LC-MS) method - specific for detecting and quantifying up to eight different nitrosamines in these drug products - for detecting and quantifying NDMA in ranitidine-containing drug products.
  • October 2019: More voluntary recalls were announced by Novitium Pharma and Lannett.
  • November 1, 2019: The FDA is issuing an update on new testing results showing NDMA levels in all ranitidine samples it tested. Levels of NDMA range from 0.03 to 2.85 parts per million, in 18 different products.
  • December 4, 2019: The FDA announces that it is requesting manufacturers to test all lots of ranitidine-containing products and not sell products that contain levels of nitrosamines above the acceptable daily intake.
  • January 2020: Appco Pharma LLC announced a voluntary recall of some lots of ranitidine, while Northwind Pharmaceuticals voluntarily recalled prescription ranitidine tablets manufactured by Glenmark Pharmaceutical Inc.
  • March 2020: According to the FDA's recalls, a total of 15 companies had issued ranitidine recalls in the United States.
  • April 2020: After further studies and a thorough investigation, the FDA has announced that it is requesting manufacturers of all prescription and over-the-counter ranitidine drugs, to immediately withdraw their products from the market.

In Its April 2020 Announcement, the FDA Revealed That the Situation Was Worse Than Reasonably Anticipated

"We didn't observe unacceptable levels of NDMA in many of the samples that we tested" said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research.

After over six months of testing, officials with the FDA revealed that not only do ranitidine products have high levels of NDMA, but they also had the potential to become even more dangerous when stored at higher than room temperatures. The FDA found that "the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity."

The FDA recommends consumers and patients to:

  • stop taking any OTC ranitidine and safely dispose of any leftover medication they may have
  • speak with a health care provider about other treatment options
  • refrain from taking their medicines to a drug take-back location in light of the current COVID-19 pandemic; instead, follow the specific disposal instructions in the medication guide or package insert.

You May Be Entitled to Significant Compensation if You Have Been Diagnosed With Cancer as a Result of Taking Zantac

If you have experienced symptoms of one of the cancers found to be caused by Zantac or ranitidine, or you have already received a cancer diagnosis, and you believe your specific cancer is the result of taking Zantac or a ranitidine product for several years, the experienced and knowledgeable team of experts at Atraxia Law can carefully evaluate your case and advise you regarding compensation for damages.

Being told that you have cancer is a devastating experience, and the effects are even worse when you find out it's from a drug you thought was helping you. We know the pain and trauma you're going through, and it's our goal to advise you on your best legal options for pursuing a claim for compensation.