Store brand versions of Zantac are being recalled from several retail chains, amid concerns that the products might contain unsafe levels of a cancer-causing chemical.
The drugs in question are manufactured by Apotex Inc. and involve 75mg and 150mg ranitidine tablets made for Walgreens Boots Alliance Inc., Walmart Inc. and Rite Aid Corp. To date, the company has not received any reports of adverse events related to use of the recalled medications.
The Apotex recall comes nearly two weeks after the U.S. Food & Drug Administration (FDA) warned that an impurity called N-nitrosodimethylamine (NDMA) had been detected in some samples of Zantac and ranitidine. NDMA is considered a probable human carcinogen, and animal tests suggest it may increase the risk for cancer, including tumors of the kidneys, liver, and gastrointestinal tract.
Consumers who purchased store-brand Zantac or ranitidine tablets from Walmart, Rite-Aid or Walgreens should call Inmar Rx Solutions at 800-967-5952 (option 1) (9:00am – 5:00-pm, EST Monday thru Friday), to arrange for their return.
Affected retailers should quarantine any store-brand Zantac in their inventory and return the products to the place of purchase.
A full list of ranitidine medications included in the Apotex recall can be found here.
Zantac (ranitidine) is indicated to treat heart burn, GERD and other acid-related digestive conditions. The drug is sold by prescription and over-the-counter in both named-brand and generic versions.
Valisure, an online pharmacy, alerted the FDA to the presence of NDMA in Zantac and ranitidine. According to the company, the cancer-causing chemical was found in every sample it tested and often at levels far above the FDA’s daily intake limits. Valisure attributed the presence of NDMA to the instability of the ranitidine molecule, which can degrade under the conditions created by digestion.
Despite these finding, the FDA has not ordered a nationwide ranitidine recall. However, it has urged consumers taking over-the-counter brands to consider switching to another antacid. Those taking Zantac or ranitidine by prescription should not stop without talking to their doctors, as doing so could cause their condition to worsen.
The FDA is still working to determine if the “low” levels of NDMA pose any health risk. Meanwhile, regulators in Canada have ordered the manufacturers of ranitidine and Zantac to suspend shipments in that country, while France’s Agence Nationale de Sécurité du Médicame ordered a recall of all generic and name-brand Zantac products sold in pharmacies.
GlaxoSmithKline, the original manufacturer of Zantac, has halted global distribution of its ranitidine products. Novartis recalled all generic prescription products manufactured by its Sandoz, Inc. subsidiary after tests confirmed the presence of NDMA at levels that exceeded the FDA limits.
Sanofi-Aventis, which markets name-brand Zantac in the United States, has indicated it has no plans to conduct a recall at this time.
Since the FDA disclosed the presence of NDMA in ranitidine, consumers around the country have begun filing Zantac lawsuits against Sanofi and other drug makers. So far, the cases include individual personal injury claims for cancer, as well as class action lawsuits filed on behalf of consumers who allegedly purchased tainted medications.
More than 15 million Americans take prescription versions of ranitidine, while millions more rely on over-the-counter and store-brand Zantac to relieve heart burn. For that reason, legal experts are bracing for a wave of litigation, with many expecting that thousands of plaintiffs will eventually file Zantac lawsuits in the United States.