WHY: 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.
INCIDENTS: 12 reports of children unscrewing the locked caps, including four reports of children ingesting the product. One child required medical attention.
HOW MANY: About 2.3 million.
FOR MORE: Call Novartis at 866-553-6742 or visit www.novartisOTC.com for more information.