Novartis Is recalling generic Zantac medications marketed by its Sandoz, Inc. subsidiary, after determining the products contain N-Nitrosodimethylamine, or NDMA.
Novartis is the first manufacturer to announce a Zantac recall since the U.S. Food & Drug Administration (FDA) warned that the cancer-causing chemical had been detected in some samples of ranitidine-containing heart burn medications.
The company is also the first to confirm that the levels of NDMA in Zantac products exceed daily limits established by the agency.
Zantac and generic versions of ranitidine are used by millions of Americans to relieve heart burn associated with GERD and other acid-related digestive disorders. The drug is sold over-the-counter and via prescription, depending on the dose.
The FDA issued its warning on September 13th, after the online pharmacy Valisure informed the agency that it had detected NDMA in every sample of Zantac and ranitidine it tested. While the agency maintained that levels found were low, it urged consumers using over-the-counter products to consider switching to another antacid. However, those taking prescription Zantac should continue using the medication as directed until they speak with their doctor, as stopping could cause their condition to worsen.
Valisure has urged the FDA to order a Zantac recall, and said its testing did, in fact, detect NDMA at levels that far exceed the agency’s daily limits. The company also maintains that the presence of NDMA is the result of the ranitidine molecule’s instability, which can degrade under certain circumstances, including those created by digestion.
The U.S. Environmental Protection Agency has declared NDMA a probable human carcinogen, as animal testing suggests exposure increases the risk for various cancers, including tumors of the liver, kidneys and gastrointestinal tract.
Last week, Novartis announced it was suspending distribution of Sandoz ranitidine products worldwide, but that would have allowed unsold medications to remain on store shelves.
Novartis’ newly-announced Zantac recall encompasses 14 lots of Ranitidine Hydrochloride Capsules (300mg and 150mg doses), including 30 count, 60 count and 500 count bottles. A complete list of the recalled products can be found here.
Novartis has asked its wholesale customers to immediately stop distribution and return any recalled Zantac products to Sandoz. Wholesalers should also request that retail pharmacies in their group to do the same.
Pharmacies should immediately stop dispensing Sandoz Ranitidine Hydrochloride Capsules and return their remaining stock to the company as directed by the recall notice.
Consumers should continue taking their medication and speak to their physician or pharmacist about alternate healthcare treatment options. Those with questions can contact Sandoz at 1-800-525-8747 option # between 8:30am – 5:00pm Monday – Friday EST or visit www.us.sandoz.com for more information.
So far Novartis has not received any reports of adverse events in connection with the Zantac recall. Patients who do experience any issues possibly related to Sandoz ranitidine products should contact their physician. They can also report any health issues or quality problems to the FDA’s MedWatch program.