American Health Packaging is recalling ranitidine tablets after tests indicated the heartburn medication contained unacceptable levels of N-Nitrosodimethylamine (NDMA), a probable human carcinogen.
According to a recall notice posted on the U.S. Food & Drug Administration’s (FDA) website, the recall includes 11 lots of Ranitidine Tablets, USP 150 mg, 100 count Unit Dose Blisters. A complete list of Lot Numbers and Expiration dates can be found here.
American Health Packaging has notified its distributor and has arranged for return of all recalled ranitidine products to lnmar Pharmaceuticals Services.
Consumers who have Ranitidine Tablets, USP included in this recall should stop using the product and can contact Inmar Pharmaceuticals Services by 800-967-5952 (option 1). Hours of operation are 9:00 am – 5:00 pm, EST Monday through Friday.
Zantac and ranitidine recalls began last fall, after the online pharmacy Valisure announced it had detected high levels of NDMA in every drug sample it tested. NDMA is a known environmental contaminant found in water and foods, including meats, dairy and vegetables. Animal testing has linked NDMA exposure to an increased risk of cancer, especially kidney, liver, and gastrointestinal cancers.
Valisure subsequently petitioned the FDA for a Zantac recall, noting that the NDMA levels detected by its tested sometimes far exceeded the agency’s recommended guidelines. The company also asserted that the instability of the ranitidine molecule resulted in the production of NDMA when the drug was subjected to conditions that mimic human digestion.
While FDA’s own tests have since found unacceptable levels in some Zantac products, the agency has yet to determine whether or not ranitidine produces NDMA in the human stomach.
Although the FDA has not ordered an across-the-board Zantac recall, numerous pharmaceutical companies have voluntarily pulled their ranitidine drugs from the market, including Appco Pharma LLC, Aurobindo Pharma USA, Sanofi, GlaxoSmithKline, Glenmark Pharmaceutical Inc., Novartis, Dr. Reddy’s Laboratories, Perrigo, Novitium Pharma, and Lannett Company.
Walmart, Walgreens, CVS, and Rite-Aid have also stopped selling prescription and over-the-counter versions of Zantac and ranitidine.
The cancer scare has also resulted in a growing number of Zantac lawsuit filings by plaintiffs across the United States. All such federal claims were recently centralized in a multidistrict litigation now underway in the U.S. District Court, Southern District of Florida. About half of the Zantac lawsuits claim NDMA-contaminated ranitidine was responsible for the development of cancer, while others seek refunds and other economic damages for consumers who allegedly purchased tainted drugs.