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The Food and Drug Administration (FDA) is alerting healthcare professionals and patients of a voluntary recall of over-the-counter (OTC) ranitidine tablets 75mg and 150mg (all pack sizes and formats) manufactured by Apotex Corp. and labeled by Walgreens, Walmart, and Rite-Aid due to the presence of the probable human carcinogen, N-nitrosodimethylamine (NDMA), at low levels.
Additionally, CVS Pharmacy has suspended the sale of all Zantac brand and CVS Health brand ranitidine products as a precautionary measure until further notice. It is important to note that the Zantac brand and CVS Health brand ranitidine products have not been recalled. Customers who purchased these products at CVS will also be given a refund.
At this time, the FDA is not advising patients to stop taking ranitidine, however, as similar therapies are available, alternative medications could be considered.
The FDA has taken appropriate steps to evaluate manufacturers for the safety of these products. A testing method to detect nitrosamine impurities in ranitidine has been posted by the FDA to be used by regulators and industries. The FDA has also requested samples of ranitidine from manufacturers to be tested by scientists at the Agency.
Additional information regarding the specific NDC numbers for the affected Ranitidine Hydrochloride Tablets can be found here. According to Apotex, there have been no reports of adverse events related to the use of the recalled product at this time.
Healthcare professionals and patients can report adverse events associated with these products to the FDA’s MedWatch Program.
For more information visit fda.gov.
