The recall covers 2.3 million bottles. There are 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 12 reports of children unscrewing the locked caps, including four reports of adverse events related to the Triaminic products. One child required medical attention.
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 most of the products have been used, returned, or quarantined.
For a full list of the recalled products, go to www.novartisOTC.com. Consumers can also call Novartis Consumer Healthcare toll-free at (866) 553-6742 from 8 a.m. to midnight ET, Monday through Saturday.