Sanofi Recalls Over-the-Counter Zantac in U.S. and Canada
October 18 2019 - 11:44AM
Dow Jones News
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 michael.dabaie@wsj.com
(END) Dow Jones Newswires
October 18, 2019 11:29 ET (15:29 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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