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FDA Alert - Voluntary Recall of Certain OTC Infants’ and Children’s Products

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling all lots that have not yet expired of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait. (SEE RECALLED PRODUCT LIST BY CLICKING LINK BELOW).

McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use.

The company is conducting a comprehensive quality assessment across its manufacturing operations and has identified ...read more


DISCLAIMER: The contents of this document are for informational purposes only. It is not a substitute for a medical exam, nor does it replace the need for services provided by a medical professional. The information provided in this document is not intended to diagnose, treat, or cure. Every effort has been made to provide accurate, up-to-date and complete information, but no warranty or guarantee is made to that effect. Healthesystems is not liable for any direct, indirect, consequential, special, exemplary, or other damages arising from the use or misuse of any material or information provided in this document.

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