McNeil Consumer Healthcare, a Division of McNeil PPC, Inc., in consultation with the U.S. Food and Drug Administration, 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, Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait.
McNeil is initiating this voluntary recall because some of these products may not meets required quality standards. This recall is not being taken 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 inactive ingredients than is specified; other may contain inactive ingredients that may not meet internal testing requirements; and other may contain tiny particles. White 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 serious harm.
For additional information, including NDC numbers, consumers should visit www.mcneilproductrecall.com or call 1-888-222-6036 (Monday – Friday, 8 a.m. to 1 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.
Copyright McNeil Consumer Healthcare, a Division of McNeil PPC, Inc. 2010.