By Colin Kellaher

The U.S. Food and Drug Administration on Wednesday said it ordered manufacturers to immediately withdraw all prescription and over-the-counter versions of the heartburn drug ranitidine from the market after finding an increased risk from a contaminant.

The agency last year said it learned of a probable human carcinogen found at low levels in some versions of Sanofi S.A.'s popular heartburn drug Zantac and its various generic forms.

On Wednesday, the FDA said it has determined that the impurity in some ranitidine products increases over time and when stored at higher-than-room temperatures, which it said could result in consumer exposure to unacceptable levels of the impurity.

Several large U.S. retailers stopped selling ranitidine products last year after the FDA issued an alert about the issue, and Sanofi voluntarily recalled Zantac in the U.S. and Canada over the contamination concerns.

The FDA said that as a result of its immediate market withdrawal request, ranitidine products won't be available for new or existing prescriptions or for over-the-counter use in the U.S.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

April 01, 2020 11:29 ET (15:29 GMT)

Copyright (c) 2020 Dow Jones & Company, Inc.
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