McNeil Consumer Healthcare Announces Voluntary Recall of
Certain OTC Infants’ and Children's Products
Fort Washington, PA (April 30, 2010) – 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 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 corrective actions that will be implemented before new manufacturing is initiated at the plant where the
recalled products were made.
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 those age groups as this could result in
For additional information, including affected NDC numbers, consumers should visit our website www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m.
to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). 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.
McNeil Consumer Healthcare, Division of McNeil-PPC, Inc. markets a broad range of well-known OTC products.