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Sandoz Inc. Issues Voluntary Recall of Zantac Over Potential Carcinogen Contamination

— September 27, 2019

Sandoz Inc. is recalling certain lots of a generic version of Zantac that may be contaminated with a cancer-causing agent.

Sandoz Inc. is recalling a generic version of Zantac, also known as prescription ranitidine hydrochloride, over concerns it may have a contaminant that might cause cancer. At the moment, 14 lots of the prescription drug is included in the recall. According to the recall notice, the capsules have “elevated levels of NDMA, a probable human carcinogen formally known as N-nitrosodimethylamine.”

Caution; Image Courtesy of Pixabay,

Fortunately, there haven’t been reports of anyone experiencing adverse reactions linked to the recalled drugs, though consumers are being urged to seek medical attention if they “experience any problems possibly related to ranitidine use.” Additionally, the U.S. Food and Drug Administration (FDA) is urging anyone currently taking the recalled ranitidine “to follow the recall instructions provided by Sandoz.”

It’s important to note, however, that not every ranitidine product is included in the recall. A list of all the recalled products can be found here. For now, the FDA is investigating ranitidine products from numerous manufacturers, including Sandoz Inc., to see “whether low levels of NDMA recently discovered in ranitidine pose a risk to patients.” In fact, Dr. Ned Sharpless, the acting FDA Commissioner said the agency “began testing ranitidine products as soon as it learned of the potential impurity.” He added, “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.”

What is prescription ranitidine? For starters, it’s a popular prescription drug often used to “treat and prevent gastroesophageal reflux disease and ulcers in the stomach and intestines,” according to the FDA.


Sandoz recalls generic Zantac due to possible carcinogen

Sandoz Inc. Issues Voluntary Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to An Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA), in the Product

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