The alarm over a carcinogenic impurity found in Zantac and generic Zantac medications escalated this week, as major drugstore chains pulled the products.
CVS, Walgreens, and Rite Aid pulled ranitidine and Zantac from their shelves as a precaution after FDA issued a new warning about the carcinogenic impurity, N-nitrosodimethylamine (NDMA), found in ranitidine and Zantac OTC and prescription medications for heartburn and other conditions.
A spokesperson for Rite Aid told The New York Times the company was “in the process of removing Zantac and generic versions sold under the Rite Aid name from its shelves.”
Walgreens said it is pulling the medication while the FDA continues its review of the products, according to The New York Times.
Sandoz also recalled certain lots of prescription Zantac and Apotex issued a recall of all of its OTC ranitidine products late last week.
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“We began testing ranitidine products immediately after we learned of the potential impurity,” said Acting FDA Commissioner Ned Sharpless, MD, in a statement from the agency. “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.”
CVS’ action is being taken “out of an abundance of caution due to a recent Product Alert from the FDA that ranitidine products may contain a low level of nitrosodimethylamine (NDMA), which is a probable human carcinogen,” said CVS in a statement.
“Zantac brand products and CVS brand ranitidine products have not been recalled, and the FDA is not recommending that patients stop taking ranitidine at this time. However, customers who purchased these products can return them to CVS for a refund,” CVS added.
CVS Pharmacy will continue to sell other over-the-counter H2 blockers, including Pepcid, Tagamet and its respective generic equivalents, famotidine and cimetidine.
“The FDA is continuing to evaluate whether low levels of NDMA in ranitidine pose a risk to patients. The levels that FDA is finding in ranitidine from preliminary tests barely exceed amounts found in common foods,” CVS said.
Meanwhile, Sandoz is voluntarily recalling 14 lots of prescription Zantac due to the impurity, FDA said in a statement.
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“The agency is testing ranitidine products from multiple manufacturers and assessing the possible effect on patients who have been taking ranitidine, as well as what manufacturers can do to reduce or eliminate nitrosamine in drugs,” FDA said.
In addition, Apotex is voluntarily recalling Ranitidine Tablets 75 mg and 150 mg (all pack sizes and formats) to the retail level on a precautionary basis, the pharma maker said in a statement on FDA’s website.
The tablets were distributed nationwide to wholesaling chains.
“Apotex has learned from the FDA and other global regulators that some ranitidine medicines including brand and generic formulations of ranitidine regardless of the manufacturer, contain a nitrosamine impurity…at low levels,” Apotex said.
The ranitidine situation has escalated quickly since mid-September, when FDA said that Zantac contains the carcinogenic impurity at very low levels. FDA “is evaluating whether the low levels of NDMA in ranitidine pose a risk to patients,” said Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, in a statement at the time.
NDMA was also found in Angiotensin II Receptor Blockers (ARBs) in 2018 and 2019.
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