06 Feb 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Novartis Pharma is voluntarily recalling certain lots of Triaminic Syrups, Theraflu Warming Relief Syrups, Jack & Jill brand pediatric syrups and Buckley's Complete Liquids as the child-resistant feature of the bottle caps may not function properly. This may lead to the removal of the cap with the tamper-evident seal still in place.
Novartis Pharma has not received any adverse events due to the tamper evident seal causing a failure of the child resistant cap. However, Novartis Consumer Health in the US 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 only 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 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 Consumer Health that determined a voluntary recall was in the best interest of consumers.