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Novartis pulls Zantac generic from market amid regulatory review for impurity

Novartis AG's generics unit Sandoz is ceasing distribution of products that contain the stomach medication ranitidine while regulators investigate whether they contain a cancer-causing chemical.

Sandoz's capsules are a generic version of Sanofi's Zantac brand, and generic ranitidine is marketed by dozens of companies globally, including Teva Pharmaceutical Industries Ltd. and Mylan NV.

"A precautionary distribution stop of all Sandoz ranitidine-containing medicines in all our markets will remain in place under further clarification, this includes capsules in the USA," a spokesperson from Novartis said in an email. "Our internal investigation is ongoing to determine further details."

Zantac and its generics are being reviewed by U.S. and EU regulators after tests showed that some batches contained a likely carcinogen called N-nitrosodimethylamine, or NDMA. The FDA warned patients and healthcare providers of the impurity Sept. 13.

"Currently, the agency is examining the levels of NDMA in ranitidine and evaluating the possible risk to patients," an FDA spokesperson said in an email Sept. 18. "The FDA will take appropriate measures based on the results of the ongoing investigation."

Health Canada became the first regulatory agency on Sept. 17 to request that companies halt distribution of the drugs until evidence shows that they do not contain the chemical. The regulator said Novartis is recalling its versions in Canada and other countries, while other products are still being sold in stores despite the distribution halt pending more potential recalls.

"This is an interim, precautionary measure as Health Canada continues to gather information from companies and to assess the issue with other international regulators," Health Canada said in a Sept. 17 release.

Sanofi said in a statement that Zantac products are not being recalled, except those in Canada, which will be held until further notice in accordance with the directive from the country's regulator. The company noted that the FDA reported levels of the cancer-causing impurity to be extremely low, and therefore, "we have no reason to believe that a recall is necessary at this point."

"We are working closely with the FDA and are conducting our own robust investigations to ensure we continue to meet the highest quality safety and manufacturing standards," Sanofi said.

NDMA is the same chemical impurity found in batches of the heart drug valsartan in 2018 that led to mass recalls of generics from several companies. Regulators have said that NDMA is a probable carcinogen, which is unsafe for a person who is exposed long-term, but likely causes no harm at lower levels.

Novartis' Sandoz unit sold almost $3.8 billion in retail generics in the first half of 2019.