McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling all lots that have not yet expired of certain over-the-counter 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.
McNeil is initiating the recall because some of these products may not meet required quality standards. The company says the recall is not being undertaken on the basis of adverse medical events. However, it says, 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 company says the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use.
Consumers can contact the company at 1-888-222-6036 and also at www.mcneilproductrecall.com. Parents and caregivers who are not sure about alternative pediatric health treatment options should talk to their doctor or pharmacist and are reminded to never give drug products to infants and children that are not intended for their age groups, as this could result in serious harm.
The recall affects all unexpired lots of Tylenol, Motrin, Zyrtec and Benadryl formulated for youngsters – more than 43 liquid products in all. Parents across the country rely on the medications to ease their children’s aches and pains, fevers and allergy-associated runny noses and sneezes.
For additional information, including affected NDC numbers, consumers should visit the company’s website www.mcneilproductrecall.com or call 1-888-222-6036. Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch. If you want a list of the recalled products you may contact Shanna Malone at Shanna.Malone@beasleyallen.com or on our web site at www.beasleyallen.com.
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