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On Sep. 13, the Food & Drug Administration (FDA) issued a public statement announcing that low levels of N-nitrosodimethylamine (NDMA) were detected in preliminary tests of the popular heartburn medication ranitidine, which is most often sold under the brand name Zantac. NDMA is a chemical agent used in rocket fuel, gasoline and as an additive to lubricants and is a known environmental contaminant that has been found in U.S. food and water supplies. NDMA is categorized as a probable human carcinogen, which means that it likely causes cancer in humans at a certain level of exposure.

The recall came less than a week after the online pharmacy Valisure submitted a petition to the FDA saying that “extremely high levels” of NDMA were detected in several ranitidine medications tested by Valisure. In the notice, Valisure states that “the [FDA] has established a permissible daily intake limit for the probable human carcinogen, NDMA, of 96 ng. Valisure has detected NDMA in excess of 3,00,000 ng per tablet when analyzing ranitidine products.” This means that Valisure researchers detected over 30,000 times the recommended daily limit of NDMA in certain ranitidine medications. The FDA conducted its own additional testing before revealing to the public on Oct. 2 that it found “unacceptable levels” of NDMA in several ranitidine medications.

As a safety precaution, multiple drug makers have issued voluntary recalls of their ranitidine medications. According to the FDA’s recalls, market withdrawals and safety alerts database, these are the ranitidine medications impacted by the recall as of Nov. 1, 2019:

  • Apotex Corp. – Ranitidine 75 and 150 mg tablets (all pack sizes)
  • Reddy’s Laboratories – Ranitidine over-the-counter medications (expiration dates from September 2019 to June 2021)
  • Lannett Company, Inc. – Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL
  • Novitium – Ranitidine Hydro-chloride prescription capsules (30, 60, 100 and 500-count)
  • Perrigo Co. – Ranitidine over-the-counter medications (all pack sizes)
  • Sandoz Inc. – Ranitidine 150 mg capsules (30, 60 and 500-count)
  • Sanofi – Zantac 150®, Zantac 150® Cool Mint and Zantac 75® over-the-counter medications

Another concern is that when unstable ranitidine molecules break down in certain conditions, including the conditions of the human digestive tract, it can create harmful levels of NDMA inside the body. This also poses the risk that NDMA will enter the sewage-treatment system and contaminate drinking water. Certain levels of NDMA exposure have been linked to several types of cancer, stomach and bladder cancer being the most commonly associated conditions. Other cancers include:

  • Colorectal Cancer
  • Esophageal Cancer
  • Intestinal Cancer
  • Kidney Cancer
  • Liver Cancer
  • Ovarian Cancer
  • Pancreatic Cancer
  • Testicular Cancer
  • Uterine Cancer

If you or a loved one has developed cancer after taking ranitidine (Zantac), please give the dangerous drug and device attorneys at Childers, Schlueter, & Smith a call at 800-641-0098 or fill out our online contact form. All initial inquiries are free of charge and without obligation.

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