Novartis Consumer Health, Inc. voluntarily recalling in the US select lots of
certain over-the-counter products due to bottle closure defect
--Voluntary recall of certain Triaminic® Syrups and Theraflu Warming Relief®
Syrups manufactured before December 2011 issued to consumers, retail customers
and wholesalers in the United States
--Consumers who may have the product(s) being recalled are asked to return the
affected products and receive a full refund
--The products being recalled were produced at the Novartis Consumer Health
Lincoln, Nebraska facility prior to the voluntary suspension of operations in
PARSIPPANY, N.J., Jan. 31, 2013
PARSIPPANY, N.J., Jan. 31, 2013 /PRNewswire/ -- Novartis Consumer Health, Inc.
announced today that it is voluntarily recalling certain lots of Triaminic^®
Syrups and Theraflu Warming Relief^® Syrups that were manufactured in the
United States before December 2011. Novartis Consumer Health has decided to
issue a voluntary recall to consumers, retail customers and wholesalers in the
US because the child-resistant feature of the bottle cap may not function
properly, enabling the cap to be removed with the tamper-evident seal still in
To view the multimedia assets associated with this release, please click
Novartis Consumer Health received four adverse events related to this issue on
bottles of Triaminic^® Syrups. There were no reports of adverse events related
to this specific issue for Theraflu Warming Relief^® Syrups.
Triaminic^® Syrups and Theraflu Warming Relief^® 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
manufacturing facility in Lincoln, Nebraska prior to the voluntary suspension
of operations and shipments at the facility in December 2011. 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.
The affected bottle sizes are attached to this release. The lot number is
located on the bottom panel of the box and on the left side of the label on
the bottle. The NDC number is located on the upper right corner of the front
panel of the Triaminic box and the upper left corner of the Theraflu bottle.
Novartis Consumer Health advises consumers who think they might have the
product(s) being recalled to visit our website at www.novartisOTC.com or
contact the Novartis Consumer Relationship Center at 866-553-6742 (available
Monday-Saturday 8 a.m. to midnight Eastern Time) for more detailed information
about the recall, including which lot numbers are impacted, and for
information on how to return the affected products and receive a full refund.
Retailers and wholesalers should stop distribution and return the affected
lots using the Novartis Product Return information that is being provided to
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 866-553-6742 (available Monday-Saturday 8 a.m. – midnight Eastern Time) or
the FDA's MedWatch Adverse Event Reporting Program either online, by regular
mail or by fax.
Regular Mail: use postage-paid FDA form 3500 available at:
Mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
This recall is being conducted with the knowledge of the US Food and Drug
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.
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
Novartis is on Twitter. Sign up to follow @Novartis at
Novartis Media Relations
+1 212 830 2465 (direct)
+1 862 579 8456 (mobile)
Novartis Consumer Health, Inc.
+1 973 503 7483 (direct)
+1 973 479 2078 (mobile)
Novartis Consumer Health, Inc.
+1 973 503 7337 (direct)
+1 862 221 0151 (mobile)
For Novartis multimedia content, please visit www.thenewsmarket.com/Novartis.
For questions about the site or required registration, please contact:
SOURCE Novartis Consumer Health, Inc.
Press spacebar to pause and continue. Press esc to stop.