Sanofi Recalls Over-the-Counter Zantac in U.S. and Canada

By Michael Dabaie

Sanofi (SNY) said it would conduct a voluntary recall of over-the-counter Zantac in the U.S. and Canada.

The pharmaceutical company said the recall is due to possible contamination with a nitrosamine impurity called N-nitrosodimethylamine, or NDMA. The company said it is working with health authorities to determine the level and extent of the recall.

The U.S Food and Drug Administration and Health Canada in September issued public statements alerting that some ranitidine medicines, including Zantac OTC, could contain NDMA at low levels and asked manufacturers to conduct testing.

Sanofi said evaluations are ongoing on both active ingredient and finished drug product. Due to inconsistencies in preliminary test results of the active ingredient used in the U.S. and Canadian products, Sanofi said it decided to conduct the recall in the U.S. and Canada as the investigation continues.

Sanofi ADRs were down about 1% to $46.10.

Write to Michael Dabaie at [e-mail]

(END) Dow Jones Newswires

October 18, 2019 11:29 ET (15:29 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.