Zantac Recall: the FDA

We first heard from the FDA regarding Zantac, ranitidine and NDMA in September 2019, when the FDA learned some ranitidine medications, including those sold under the brand-name Zantac, contained nitrosamine impurities known as N-nitrosodimethylamine, or NDMA. NDMA is known to be a “probable” human carcinogen based on lab tests and is a known environmental contaminant. Prior to hearing about NDMA in Zantac and ranitidine, NDMA was found in blood pressure and heart failure medications, leading to drug recalls.

  • In September, the FDA was simply evaluating whether the relatively low levels of NDMA they found in Zantac and ranitidine were dangerous to consumers. At this time, the FDA did not tell consumers to stop taking Zantac and ranitidine and began working with international regulators to determine the source of the impurity.
  • A couple of weeks later, the FDA alerted health care professionals and patients of a voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz due to NDMA impurities found in the medication. The FDA stated that while they investigated the risks, consumers and patients could continue taking any ranitidine that had not been recalled, and that they would continue their investigation, testing ranitidine products from multiple manufacturers. The FDA requested manufacturers begin their own laboratory testing to examine levels of NDMA in ranitidine, and to send samples to the FDA to be tested by their own scientists.
  • Only two days later, on September 26, 2019, the FDA once again alerted health care professionals and consumers of a voluntary recall of over-the-counter ranitidine tablets, both 75 mg. and 150 mg., labeled by Walgreens, Walmart and Rite-Aid, and manufactured by Apotex Corporation due to NDMA impurities found in the drugs. Not all ranitidine and Zantac medications marketed in the U.S. were recalled at this time, and, once again, the FDA did not recommend that individuals stop taking their ranitidine drugs. At this time, the FDA posted a testing method to be used by regulators to detect NDMA in ranitidine.
  • On October 23, 2019, the FDA released a second liquid chromatography-mass spectrometry method for detecting and quantifying NDMA in ranitidine and Zantac. This second method uses a more widely available technology than the first posted method. Dr. Reddy’s Laboratories LTD voluntarily recalled all their prescription and over-the-counter ranitidine tablets and capsules manufactured by the company at this time, and the FDA cautiously said that consumers taking OTC ranitidine might want to consider using another product for heartburn relief.
  • On October 28, 2019, Perrigo Company voluntarily recalled OTC ranitidine tablets of all pack sizes, Novitium Pharma voluntarily recalled all unexpired quantities and lots of ranitidine capsules, and Lannett Company voluntarily recalled all unexpired lots of prescription ranitidine syrup, USP, 15 mg/mL.
  • On November 1, 2019, the FDA posted lab results showing NDMA levels in ranitidine tablet and syrup samples it tested. After stating that 0.32 parts per million of NDMA per day is considered reasonably safe for human ingestion based on lifetime exposure, the FDA set acceptable NDMA ranitidine levels at 0.32 parts per million, recommending recalls to any manufacture whose ranitidine tests higher. At this point, the FDA determined the levels of NDMA in ranitidine were similar to the levels you would expect to be exposed to if you often ate smoked or grilled meats.
  • On November 8, 2019, Aurobindo Pharma recalled over-the-counter ranitidine tablets (150 mg), prescription ranitidine capsules (150 mg. and 300 mg) and ranitidine syrup (15 mg/mL) due to unacceptable levels of NDMA.
  • On November 12, 2019, there were two more voluntary recalls of ranitidine: Amneal voluntarily recalled prescription ranitidine tablets (150 mg. and 300 mg.) and ranitidine syrup (15 mg/mL) manufactured by Amneal Pharmaceuticals LLC. American Health Packaging voluntarily recalled eight lots of ranitidine syrup (150 mg/10 mL) liquid unit dose cups manufactured by Lannett Company. The FDA advised companies to recall their ranitidine if testing showed levels of NDMA above the acceptable daily intake of 0.32 parts per million.
  • On November 22, 2019, Golden State Medical Supply voluntarily recalled ranitidine capsules (150 mg. and 300 mg.) manufactured by Novitium, and Precision Dose Inc., voluntarily recalled ranitidine oral solution, USP 150 mg/10 mL, manufactured by Amneal Pharmaceuticals, LLC.
  • On December 4, 2019, the FDA asked manufacturers of ranitidine to expand NDMA testing to include all lots of the medication prior to selling to consumers. Any testing that shows NDMA levels above 0.32 parts per million, must inform the agency immediately.
  • On December 18, 2019, Glenmark Pharmaceuticals issued a voluntary recall of ranitidine tablets (150 mg. and 300 mg.) due to unacceptable levels of NDMA.
  • On January 8, 2020, Mylan voluntarily recalled their prescription ranitidine and nizatidine capsules due to unacceptable levels of NDMA. Appco Pharma, LLC voluntarily recalled their prescription ranitidine capsules, and Northwind Pharmaceuticals voluntarily recalled their prescription ranitidine tablets (150 mg. and 300 mg.) manufactured by Glenmark Pharmaceutical.
  • On February 27, 2020, Amneal Pharmaceuticals, LLC voluntarily recalled their 150 mg. ranitidine tablets due to unacceptable levels of NDMA.
  • Finally, on April 1, 2020, the FDA issued an across-the-board prescription and OTC ranitidine and Zantac tablets and syrups. The agency stated they had determined that the NDMA impurities in some ranitidine products increased over time, and when stored at higher than room temperatures, the NDMA could be found at unacceptable levels. The FDA stated that “We didn’t observe unacceptable levels of NDMA in many of the samples we tested. However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless the quality can be assured.”

To see a full list of all lots of Zantac and ranitidine recalled, go to https://www.drugs.com/fda-alerts/1991-1283.html.

Getting Legal Help with a Zantac Cancer Lawsuit - If you have been diagnosed with cancer after taking Zantac or generic ranitidine you could benefit from speaking to an experienced Zantac attorney to discuss the facts of your case. Following the Zantac recall, many Zantac manufacturers are seeing lawsuits filed against them, many of those lawsuits claiming the manufacturers were aware of the Zantac cancer risk, and knew of the high levels of NDMA in Zantac, yet failed to warn the public. Now that the FDA has issued a Zantac recall, more lawsuits will almost certainly be filed. Contacting a Houston Sullo & Sullo Zantac attorney could be very beneficial. We will ensure your rights and your future are properly protected.

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