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PANAMA CITY, Panama -- Novartis Pharma Logistics is voluntarily recalling certain lots of Triaminic Syrups, Theraflu Warming Relief Syrups, Jack & Jill brand pediatric syrups and Buckley's Complete Liquids in Aruba, Barbados, The Bahamas, Curacao, Jamaica and Trinidad and Tobago.

Novartis decided to issue a voluntary recall to consumers, retail customers and wholesalers in the affected countries 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 place.

Novartis 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.

Triaminic Syrups, Theraflu Warming Relief Syrups, Jack & Jill brand pediatric syrups and Buckley's Complete Liquids continue to be safe and effective when used as directed on the package label.

The products being recalled were produced at a Novartis Consumer Health manufacturing facility in the US prior to the voluntary suspension of operations in December 2011. In addition to production at in the US, Buckley's Complete was also produced until January 2013 at a third-party manufacturing site in Canada. A consumer complaint in the US in late November 2012 triggered an internal investigation by Novartis that determined a voluntary recall was in the best interest of consumers.

Action to be taken by consumers

Novartis advises consumers who believe they have product included in this recall to discontinue use and return the recalled product to the store or pharmacy where it was purchased for a full refund. Only recalled product in the original bottle will be eligible for a refund. Consumers may contact the Novartis Consumer Relationship Center at 877-769-8420 (available Monday-Saturday 8 a.m. to 6 p.m. Eastern Time) for more detailed information about the recall, including which products are impacted, and for information on how to return the affected products and receive a full refund.

Action to be taken by retailers and wholesalers

Retailers and wholesalers should stop distribution and return the affected lots using the Novartis Product Return information that is being provided to them. Retailers that receive product returns from consumers will be reimbursed by Novartis Pharma Logistics.

This recall is being conducted with the full knowledge of the ministries of health in the respective countries.

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