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September 25, 2019

Sandoz recalls generic Zantac due to possible carcinogen

GI medication has elevated levels of NDMA

A voluntary recall of a generic version of Zantac has been issued because the drug has been found to contain a contaminant that could cause cancer.

Sandoz Inc. is recalling 14 lots of prescription ranitidine hydrochloride capsules determined to have elevated levels of NDMA, a probable human carcinogen formally known as N-nitrosodimethylamine.

Sandoz has not received any reports of adverse events related to the recalled products, company officials said. But consumers are urged to contact their health care providers if they experience any problems possibly related to ranitidine use.

The U.S. Food and Drug Administration urged patients taking any of the recalled ranitidine – found here – to follow the recall instructions provided by Sandoz.

Not all ranitidine products are being recalled. That includes the ranitidine sold under the brand name Zantac, produced by Sanofi.

The FDA announced last week that it was investigating whether low levels of NDMA recently discovered in ranitidine pose a risk to patients. The FDA is testing ranitidine products from multiple manufacturers.

Acting FDA Commissioner Dr. Ned Sharpless said the agency began testing ranitidine products as soon as it learned of the potential impurity.

"We will continue to investigate and work to ensure these types of impurities do not exceed acceptable limits, so that patients can continue taking the medicines they need without concern," Sharpless said in a statement issued Tuesday.

Prescription ranitidine, including some the pills being recalled, is used to treat and prevent gastroesophageal reflux disease and ulcers in the stomach and intestines, according to the FDA. An over-the-counter version is used to prevent and relieve heartburn associated with acid ingestion and sour stomach.

Consumers with questions about the recall can contact Sandoz at 1-800-525-8747 on weekdays between 8:30 a.m. and 5 p.m. EST.

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