McNeil Voluntarily Recalls Certain OTC Infants' and Children's Products

Affected products include liquid versions of infant and children's Tylenol, Motrin, Zyrtec and Benadryl.

May 04, 2010

FORT WASHINGTON, Pa. - 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.

The product list includes certain liquid infant??s and children??s Tylenol, Motrin, Zyrtec, and Benadryl products. For the complete list, visit www.mcneilproductrecall.com.

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 corrective actions that will be implemented before new manufacturing is initiated at the plant where the recalled products were made.

There are a number of other products on the market, including generic versions of the recalled products, which are intended for use in infants and children and are not affected by the recall. Consumers who have the affected products can request a refund or a coupon from McNeil Consumer Healthcare via its Web site.

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