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McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC
Infants’ and Children’s Products
FOR IMMEDIATE RELEASE - April 30, 2010 – Fort Washington, PA. 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
http://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.
PRODUCTS
NDC Number
CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. GRAPE 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 FLAVOR CHILDREN’S TYLENOL® SUSPENSION 1 OZ. CHERRY BLAST FLAVOR – SAMPLE CHILDREN’S TYLENOL® SUSPENSION 4 OZ. CHERRY BLAST FLAVOR – HOSPITAL CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COUGH & SORE THROAT CHERRY FLAVOR CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COUGH & RUNNY NOSE CHERRY FLAVOR CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. COLD & STUFFY NOSE GRAPE FLAVOR CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. COLD & COUGH GRAPE FLAVOR CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. 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 BUBBLEGUM FLAVOR CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR 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 50580-730-15 CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 0.5 OZ. BUBBLEGUM CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 2 X 4 OZ. BUBBLEGUM LIQUID 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

Source: http://www.town.northborough.ma.us/Pages/NorthboroughMA_BOH/OLD%20INFORMATION/Infant_ChildRecall.pdf