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:
    • Fax toll-free to 1-866-678-6789, or
    • 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.

For further information:

Novartis Media Relations 

Julie Masow
Novartis Corporation
+1 212 830 2465 (direct)
+1 862 579 8456 (mobile)
julie.masow@novartis.com 

Pamela McKinlay
Novartis Consumer Health, Inc.
+1 973 503 7337(direct)
+1 862 221 0151(mobile)
pamela.mckinlay@novartis.com 

Milicent Brooks
Novartis Consumer Health, Inc.
+1 973 503 7483(direct)
+1 973 479 2078 (mobile)
milicent.brooks@novartis.com

Andrea Gilpin
Novartis Pharma Canada inc.
+1 514 631 6775 (x3356) (direct)
+1 514 465 2114 (cellulaire)
andrea.gilpin@novartis.com 

e-mail: us.mediarelations@novartis.com 

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