Updated: Friday, 01 Feb 2013, 11:44 AM EST
Published : Friday, 01 Feb 2013, 10:52 AM EST
Some bottles of Triaminic® Syrups and Theraflu Warming Relief® Syrups are being recalled because the child-resistant bottle caps may be defective.
The recall covers 142 production lots of Triaminic syrups and 41 lots of Theraflu syrups. Novartis, which produces the medicines, says the defect could allow for the removal the cap without breaking the seal on the bottle. The company says it received four reports of adverse events related to the Triaminic products. The child-resistant caps can fail to function properly and enable the cap to be removed by a child with the tamper-evident seal in place, posing a risk of unintentional ingestion and poisoning. These products contain acetaminophen and diphenhydramine which are required by the Poison Prevention Packaging Act to be sealed with child-resistant packaging.
The products were made between May 2010 and December 2011 at a Novartis facility in Nebraska. Novartis shut down that plant in December 2011 after federal inspections found numerous quality-control problems.
Novartis says it believes 97 percent of the inventory has been used, returned, or quarantined.
Call Novartis Consumer Healthcare toll-free at (866) 553-6742 from 8 a.m. to midnight ET, Monday through Saturday, or access more information online at www.novartisOTC.com .
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