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FDA Alerts Health Care Professionals and Patients to Voluntary Recall of Ranitidine Medicines

September 27, 2019 -- The U.S. Food and Drug Administration is alerting health care professionals and patients to a voluntary recall of over-the-counter (OTC) ranitidine tablets (75 mg and 150 mg), labeled by Walgreens, Walmart, and Rite-Aid and manufactured by Apotex Corp. These medicines may contain low levels of a nitrosamine impurity called N-nitrosodimethylamine (NDMA). Consumers taking OTC ranitidine, which is used to prevent and relieve heartburn associated with acid ingestion and sour stomach, may consider using other OTC products approved for their condition.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.

This recall follows a recent FDA statement about NDMA impurities detected in ranitidine medicines. The agency also recently alerted patients and health care professionals of Sandoz Inc.’s voluntary recall of prescription ranitidine hydrochloride capsules due to an NDMA impurity on Sept. 23.

What patients should know

  • Not all ranitidine medicines marketed in the U.S. are being recalled.
  • FDA is not recommending individuals stop taking all ranitidine medicines at this time.
  • Consumers taking OTC ranitidine could consider using other OTC products approved for their condition.
  • Patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as ranitidine.

What health care professionals should know

  • Multiple drugs are approved for the same or similar uses as ranitidine. Health care professionals should discuss other treatment options with patients who are concerned about ranitidine.
  • If you have samples of recalled ranitidine, do not provide them to patients.

FDA’s actions

FDA is continuing to test ranitidine products from multiple manufacturers and assess the possible effect on patients who have been taking ranitidine. Additionally, FDA recently posted a testing method, which can be used by regulators and industry to detect nitrosamine impurities in ranitidine. FDA has asked ranitidine manufacturers to conduct laboratory testing to examine levels of NDMA in ranitidine and to send samples of ranitidine to the agency to be tested by our scientists.

FDA will take appropriate measures based on the results of this ongoing investigation. Some manufacturers have chosen to stop distribution of ranitidine as a precautionary measure while the FDA and other international regulators conduct their investigations of the NDMA impurity.

FDA continues to evaluate the safety of ranitidine and will provide more information as it becomes available.

Source: FDA

Posted: September 2019