Novartis Consumer Health Canada Inc. issues voluntary recall of certain over-the-counter products due to bottle closure defect
-- Voluntary recall of Triaminic®and Jack & Jill®brand pediatric
syrups and adult Buckley's Complete®liquids and
NeoCitran®syrups issued to consumers
-- There were no adverse events related to this issue reported to
Novartis Consumer Health Canada, and Triaminic® and Jack &
Jill® pediatric syrups, and adult Buckley's Complete®liquids
and NeoCitran®syrups continue to be safe and effective when
used as directed on the package label
-- The products being recalled were produced at the Novartis
Consumer Health Lincoln, Nebraska facility prior to the
voluntarily suspension of operations in December 2011, and at a
third-party manufacturing site using the same bottle and cap
components.
MISSISSAUGA, ON, Jan. 31, 2013 /CNW/ – Novartis Consumer Health Canada
Inc. announced today that it is voluntarily recalling Triaminic(®) and Jack & Jill(®) pediatric syrups, NeoCitran(®) syrups and certain Buckley’s Complete(®) liquids. Novartis Consumer Health Canada Inc. has decided to issue a
voluntary recall to consumers, retail customers and wholesalers because
the child-resistant feature of the bottle cap may not function
properly, enabling the cap to be removed when the tamper-evident seal
is still in place.
The products being recalled were produced at the Novartis Consumer
Health manufacturing facility in Lincoln, Nebraska prior to the
voluntarily suspension of operations in December 2011. In addition to
production at the Lincoln site, Buckley’s Complete(®) was also manufactured until January 2013 at a third-party site using
the same Lincoln bottle and cap components. A consumer complaint in
the US in late November 2012 triggered an internal investigation by
Novartis Consumer Health that determined a voluntary recall was in the
best interest of consumers.
Novartis Consumer Health Canada, Inc. has not received any adverse
events due to the tamper evident seal causing a failure of the child
resistant cap. Novartis Consumer Health in the United States received
four adverse events for Triaminic(®) Syrups related to this issue.
All Triaminic(®), Jack & Jill(®), Buckley’s Complete(®) and NeoCitran(®) products continue to be safe and effective when used as directed on the
package label.
Novartis Consumer Health Canada Inc. advises consumers who think they
might have the product(s) being recalled to visit our website at www.novartisOTCcanada.com or contact the Novartis Consumer Relationship Center at 1-866-513-6742
(Monday-Saturday 8 am – midnight Eastern Time) for more detailed
information, including how to return the affected products.
Adverse events that may be related to the failure of child-resistant
packaging of these products may be reported to the Novartis Consumer
Relationship Center at 1-866-513-6742 (Monday-Saturday 8 am – midnight
Eastern Time) or the Health Canada’s Adverse Event Reporting Program
by:
-- Report online at
www.healthcanada.gc.ca/medeffect
-- Call toll-free at 1-866-234-2345
-- Complete a Canada Vigilance Reporting Form and:
o Fax toll-free to 1-866-678-6789, or
o Mail to: Canada Vigilance Program, Health Canada, Postal Locator
0701D, Ottawa, K1A 0K9
This recall is being conducted with the knowledge of Health Canada.
Disclaimer
The foregoing release contains forward-looking statements including
express or implied discussions regarding potential future revenues from
Novartis OTC products. You should not place undue reliance on these
statements. Such forward-looking statements reflect the current views
of management regarding future events, and involve known and unknown
risks, uncertainties and other factors that may cause actual results to
be materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no
guarantee that Novartis OTC products will achieve any particular levels
of revenue in the future. In particular, management’s expectations
regarding such products could be affected by, among other things,
unexpected regulatory actions or delays or government regulation
generally; competition in general; government, industry and general
public pricing pressures; unexpected manufacturing issues; the impact
that the foregoing factors could have on the values attributed to the
Novartis Group’s assets and liabilities as recorded in the Group’s
consolidated balance sheet, and other risks and factors referred to in
Novartis AG’s current Form 20-F on file with the US Securities and
Exchange Commission. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect, actual
results may vary materially from those anticipated, believed, estimated
or expected. Novartis is providing the information in this press
release as of this date and does not undertake any obligation to update
any forward-looking statements contained in this press release as a
result of new information, future events or otherwise.
About Novartis
Novartis provides innovative healthcare solutions that address the
evolving needs of patients and societies. Headquartered in Basel,
Switzerland, Novartis offers a diversified portfolio to best meet these
needs: innovative medicines, eye care, cost-saving generic
pharmaceuticals, preventive vaccines and diagnostic tools,
over-the-counter and animal health products. Novartis is the only
global company with leading positions in these areas. In 2012, the
Group achieved net sales of USD 56.7 billion, while R&D throughout the
Group amounted to approximately USD 9.3 billion (USD 9.1 billion
excluding impairment and amortization charges). Novartis Group
companies employ approximately 128,000 full-time-equivalent associates
and operate in more than 140 countries around the world. For more
information, please visit http://www.novartis.com.
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SOURCE Novartis Pharmaceuticals Canada Inc.
