Microsoft word - 47138.doc

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 serious harm. 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. Note: Product NDC numbers can be located on the label of the bottle above the brand name PRODUCTS 
NDC Number 
CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. GRAPE FLAVOR CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE FLAVOR* CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. CHERRY DYE FREE CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. CHERRY FLAVOR CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. CHERRY FLAVOR CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE - HOSPITAL CONCENTRATED TYLENOL® INFANTS’ DROPS 0.25 OZ. GRAPE - SAMPLE CHILDREN’S TYLENOL® SUSPENSION 2 OZ. CHERRY BLAST FLAVOR CHILDREN’S TYLENOL® SUSPENSION 4 OZ. CHERRY BLAST FLAVOR CHILDREN’S TYLENOL® DYE-FREE SUSPENSION 4 OZ. CHERRY FLAVOR CHILDREN’S TYLENOL® SUSPENSION 4 OZ. GRAPE SPLASH CHILDREN’S TYLENOL® SUSPENSION 4 OZ. BUBBLEGUM FLAVOR CHILDREN’S TYLENOL® SUSPENSION 4 OZ. VERY BERRY STRAWBERRY CHILDREN’S TYLENOL® SUSPENSION 1 OZ. CHERRY BLAST FLAVOR – CHILDREN’S TYLENOL® SUSPENSION 4 OZ. CHERRY BLAST FLAVOR – CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COUGH & SORE THROAT CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COUGH & RUNNY NOSE CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. COLD & CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. COLD & CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. MULTI- CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. FLU BUBBLEGUM FLAVOR CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COLD GRAPE FLAVOR CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COLD & ALLERGY CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. MULTI-SYMPTOM COLD CONCENTRATED MOTRIN® INFANTS’ DROPS 1 OZ. BERRY DYE FREE CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY DYE FREE CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY FLAVOR* CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY DYE FREE CHILDREN’S MOTRIN® SUSPENSION 2 OZ. BERRY FLAVOR CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY FLAVOR CHILDREN’S MOTRIN® SUSPENSION 4 OZ. TROPICAL PUNCH FLAVOR CHILDREN’S MOTRIN® SUSPENSION 4 OZ. GRAPE FLAVOR CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BUBBLEGUM FLAVOR CHILDREN’S MOTRIN® SUSPENSION 1 OZ. GRAPE SAMPLE CHILDREN’S MOTRIN® SUSPENSION 1 OZ. BUBBLEGUM SAMPLE CHILDREN’S MOTRIN® SUSPENSION 1 OZ. BERRY SAMPLE CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY HOSPITAL CHILDREN’S MOTRIN® SUSPENSION 4 OZ. COLD BERRY FLAVOR CHILDREN’S ZYRTEC® LIQUIDS IN BOTTLES CHILDREN’S ZYRTEC® 4 OZ. BUBBLEGUM SYRUP CHILDREN’S ZYRTEC® DYE FREE 4 OZ. GRAPE SYRUP CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 0.5 OZ. GRAPE CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 0.5 OZ. BUBBLEGUM CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 2 X 4 OZ. BUBBLEGUM CHILDREN'S BENADRYL® ALLERGY LIQUIDS IN BOTTLES CHILDREN'S BENADRYL® ALLERGY 4 OZ. BUBBLEGUM FLAVORED LIQUID * CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE FLAVOR is also included in JOHNSON'S ® Baby Relief Kit. *CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY FLAVOR is also included in JOHNSON'S ® Baby Relief Kit.

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