API

Novartis recalls generic Zantac in U.S.

Sep 26, 2019

Novartis' Sandoz is now voluntarily recalling all quantities and lots of its prescription ranitidine capsules in the U.S. because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA.

The move builds on the Swiss drugmaker's decision last week put the brakes on its distribution the popular heartburn medicine as regulators investigated reports that it could be contaminated with the possible carcinogen.

Sandoz says it has not received any reports of adverse events related to use of the product as part of this recall to date.

GlaxoSmithKline, the original brand maker of Zantac, halted global distribution earlier this week, as well as recalled the drug in India and Hong Kong. GSK does not market its version of the drug in the U.S. GSK said its recalled medicine is made with an API from two India-based suppliers, Dr. Reddy’s Laboratories and Saraca Laboratories.

Read the Novartis press release

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