BRIDGEWATER, N.J., Oct. 18, 2019 /PRNewswire/ -- As a precautionary
measure, Sanofi will conduct a voluntary recall of Zantac OTC
(over-the-counter) in the U.S. and Canada. This recall is being taken due to
possible contamination with a nitrosamine impurity called
N-nitrosodimethylamine (NDMA). The company is working with health
authorities to determine the level and extent of the recall.
On September 13, 2019, the U.S
Food and Drug Administration and Health Canada issued public
statements alerting that some ranitidine medicines, including
Zantac OTC, could contain NDMA at low levels and asked
manufacturers to conduct testing.
Evaluations are ongoing on both drug substance (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 has made the decision to conduct the
voluntary recall in the U.S. and Canada as the investigation continues.
Active ingredients used in Sanofi's ranitidine products outside
of the U.S. and Canada are sourced
from different suppliers. Sanofi is committed to transparency and
will continue to communicate results with health authorities from
the ongoing testing, and work with them to make informed decisions
based on available data and evidence.
Sanofi encourages anyone using Zantac OTC to speak with their
health care providers or pharmacists if they have any additional
questions.
About Sanofi
Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on
human health. We prevent illness with vaccines, provide innovative
treatments to fight pain and ease suffering. We stand by the few
who suffer from rare diseases and the millions with long-term
chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
Media
Relations Contact Ashleigh Koss
Tel.: 908-981-8745 Ashleigh.Koss@sanofi.com
|
Investor Relations
Contact George Grofik
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com
|
|
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined
in the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements are statements that are not
historical facts. These statements include projections and
estimates regarding the marketing and other potential of the
product, or regarding potential future revenues from the product.
Forward-looking statements are generally identified by the words
"expects", "anticipates", "believes", "intends", "estimates",
"plans" and similar expressions. Although Sanofi's management
believes that the expectations reflected in such forward-looking
statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various
risks and uncertainties, many of which are difficult to predict and
generally beyond the control of Sanofi, that could cause actual
results and developments to differ materially from those expressed
in, or implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the absence of guarantee that
the product will be commercially successful, the uncertainties
inherent in research and development, including future clinical
data and analysis of existing clinical data relating to the
product, including post marketing, unexpected safety, quality or
manufacturing issues, competition in general, risks associated with
intellectual property and any related litigation and the ultimate
outcome of such litigation, and volatile economic conditions, as
well as those risks discussed or identified in the public filings
with the SEC and the AMF made by Sanofi, including those listed
under "Risk Factors" and "Cautionary Statement Regarding
Forward-Looking Statements" in Sanofi's annual report on Form 20-F
for the year ended December 31, 2018.
Other than as required by applicable law, Sanofi does not undertake
any obligation to update or revise any forward-looking information
or statements.
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SOURCE Sanofi