In conjunction with the United States Food and Drug Administration (FDA), McNeil Consumer Healthcare, a division of Johnson & Johnson, announced a voluntary recall of infant and children’s medications due to manufacturing defects which may affect the quality, purity, or potency of these children’s medications. The children’s medications recall involves 43 infant and child liquid formulations of Tylenol, Motrin, Zyrtec, and Benadryl.

The voluntary recall comes after an April 19, 2010 FDA inspection of a McNeil manufacturing plant in Fort Washington, Pa. No injuries or deaths related to the children’s medications under recall have been reported to date. Although the chance of injury from any of the recalled children’s medications is remote, the FDA is investigating the affected children’s medications and will provide updates as more information is uncovered. Consumers are advised not to use any of the recalled children’s medications.

According to a McNeil Consumer Healthcare news release, some of the products included in the recall may contain a higher concentration of the active ingredient than is specified. Other products may contain inactive ingredients that do not meet internal testing requirements, and other products may contain tiny particles. If children who have taken any of the recalled children’s medications have unusual symptoms, their parents are advised to contact a healthcare professional. Generic versions of the recalled children’s medications are not affected by the recall, so parents are advised to check the labeling of these products and use them as alternatives. For more information on this product recall, visit www.mcneilproductrecall.com.

Recalled products may be returned for a refund or exchanged for a fresh product once these manufacturing issues have been resolved. Although McNeil has not publicly announced how many units of the affected children’s medications were being recalled, the number is likely to be significant. Recalled products were distributed in the U.S., Canada, Dominican Republic, Dubai, Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait.

Source:

Food and Drug Administration News Release, 1 May 2010.