Mcneil consumer healthcare announces voluntary recall of certain otc infants’ and children’s products
McNeil Consumer Healthcare Announces Voluntary Recall of C.
http://www.fda.gov/Safety/Recalls/ucm210443.htm
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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
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
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, MD20852-9787, or on the MedWatch website at www.fda.gov/medwatch 1.|
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 FLAVOR
CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE FLAVOR*
McNeil Consumer Healthcare Announces Voluntary Recall of C.
http://www.fda.gov/Safety/Recalls/ucm210443.htm
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
CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. COLD & COUGH GRAPE FLAVOR
CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE
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
McNeil Consumer Healthcare Announces Voluntary Recall of C.
http://www.fda.gov/Safety/Recalls/ucm210443.htm
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. COLD BERRY FLAVOR
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 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
*CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY FLAVOR is also included in JOHNSON'S ® Baby
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