Vanderbilt University Medical Center (VUMC) is responding to a recent, widespread voluntary recall of certain ranitidine (Zantac®) oral tablets, capsules and solution from various manufacturers. The recall is due to trace contamination with a probable human carcinogen. The FDA has performed a full assessment of the contamination in multiple ranitidine products and has concluded the risk is low and similar to levels one might be exposed to if they were to eat grilled or smoked meats.
Along with the FDA, VUMC is advising patients taking over the counter (OTC) ranitidine to switch to other similar alternatives to treat their condition. Patients taking prescription ranitidine should speak with their health care provider about other treatment options as well.
In addition, most ranitidine products are currently unavailable for purchase due to these recalls which must be considered when managing your therapy or considering options for current patients.
Here is a link to the FDA’s most recent position statement regarding the recent ranitidine recalls - https://www.fda.gov/news-events/press-announcements/statement-new-testing-results-including-low-levels-impurities-ranitidine-drugs
The recall was reviewed, and recommendations made by VUMC Departments of Quality, Safety and Risk Prevention, Risk Management, Pharmacy, and Toxicology.
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Donna Seger, MD
Tennessee Poison Center
Poison Help Hotline: 1-800-222-1222