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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.

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