While its peers recalled their generic versions of Zantac, Sanofi, maker of the branded version in the U.S., bided its time as the FDA investigated the risks posed by a potentially dangerous impurity found in the drugs. Now, it has capitulated—sort of.
Sanofi says it will voluntarily recall Zantac OTC (over-the-counter) in the U.S. and Canada as a precautionary measure because of possible contamination with a nitrosamine impurity called N-nitrosodimethylamine (NDMA), a suspected carcinogen. But while Novartis and others are recalling all unexpired lots, the French drugmaker says it is “working with health authorities to determine the level and extent" of its recall.
Sanofi explained in its announcement that it continues to evaluate both the active pharmaceutical ingredient (API) and the finished form of the drug. It said that it gets the API for the drugs sold inside and outside the U.S. and Canada from different sources.
“Due to inconsistencies in preliminary test results of the active ingredient used in the U.S. and Canadian products, Sanofi has made the decision to conduct the voluntary recall in the U.S. and Canada as the investigation continues,” the drugmaker said.
Sanofi, which licenses Zantac from GlaxoSmithKline for the U.S. and Canada, last year reported €127 million ($141 million) in Zantac sales, up 13.7% in constant currencies.
Sanof’s move follows voluntary recalls of all unexpired products to the consumer level by a handful of drugmakers that manufacture generic Zantac. Novartis was the first to act, pulling its products as soon as the FDA warned of the risk of NDMA in the products. Dr. Reddy’s Laboratories and Apotex also began recalling drugs. Since then, the FDA has said early tests have found “unacceptable levels" of NDMA in samples of ranitidine.
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GlaxoSmithKline and Teva, neither of which sell Zantac versions in the U.S., are voluntarily recalling at least some of their products from other markets.
The recalls have become somewhat superfluous in the U.S., because the largest pharmacy retailers—CVS, Rite Aid, Walmart and Walgreens—have announced they will temporarily quit selling the products and remove them from their shelves.
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The FDA has now reported that further tests found unacceptably high levels of the impurity in the drug, prompting more drugmakers to initiate voluntary recalls. Earlier this month, GlaxoSmithKline, the original developer of Zantac, said it was recalling its ranitidine from markets outside the U.S.
NDMA is one of the suspected carcinogens regulators last year determined could actually be created during the manufacturing of sartan blood pressure medicines. That discovery led to a global recall of many of those drugs and prompted the FDA to do further testing.