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Recall of Kids' Tylenol, Motrin, Zyrtec, Benadryl

43 Liquid Child/Infant Products Recalled by Johnson and Johnson's McNeil Division

By Daniel J. DeNoon
WebMD Health News

Reviewed By Michael W. Smith, MD

May 2, 2010 -- Manufacturing defects have led to the recall of 43 child and infant liquid formulations of Tylenol, Motrin, Zyrtec, and Benadryl by McNeil, a division of Johnson & Johnson.

No injuries or deaths have yet been reported. The voluntary recall follows an April 19 FDA inspection of a McNeil plant in Fort Washington, Pa. that uncovered "manufacturing deficiencies," the Washington Post reports.

The company says the chances of injury from one of the recalled products are "remote." Yet consumers are warned not to use the recalled products.

"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," a company news release states.

If children who have taken the recalled products have unusual symptoms, parents are urged to contact a health care professional.

Parents should not give children adult formulation of the medications. Alternative brands of the products, including generic medications, are available. Parents who have questions about alternative treatments should consult their child's pediatrician.

Recalled products may be returned for a refund or exchanged for a fresh product once manufacturing issues have been resolved.

McNeil did not say how many units were being recalled, but the number likely is huge. Recalled products were distributed in the U.S., Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait.

List of Recalled Products

Here's a complete list of the products:

PRODUCTS NDC Number
STYLENOL INFANTS' DROPS
CONCENTRATED TYLENOL INFANTS' DROPS 1 OZ. GRAPE FLAVOR 50580-144-01
CONCENTRATED TYLENOL INFANTS' DROPS 0.5 OZ. GRAPE FLAVOR* 50580-144-15
CONCENTRATED TYLENOL INFANTS' DROPS 1 OZ. CHERRY DYE FREE 50580-167-01
CONCENTRATED TYLENOL INFANTS' DROPS 0.5 OZ. CHERRY FLAVOR 50580-143-15
CONCENTRATED TYLENOL INFANTS' DROPS 1 OZ. CHERRY FLAVOR 50580-143-30
CONCENTRATED TYLENOL INFANTS' DROPS 0.5 OZ. GRAPE - HOSPITAL 50580-144-18
CONCENTRATED TYLENOL INFANTS' DROPS 0.25 OZ. GRAPE - SAMPLE 50580-144-40
CHILDREN'S TYLENOL SUSPENSIONS
CHILDREN'S TYLENOL SUSPENSION 2 OZ. CHERRY BLAST FLAVOR 50580-123-02
CHILDREN'S TYLENOL SUSPENSION 4 OZ. CHERRY BLAST FLAVOR 50580-123-04
CHILDREN'S TYLENOL DYE-FREE SUSPENSION 4 OZ. CHERRY FLAVOR 50580-166-04
CHILDREN'S TYLENOL SUSPENSION 4 OZ. GRAPE SPLASH 50580-296-04
CHILDREN'S TYLENOL SUSPENSION 4 OZ. BUBBLEGUM FLAVOR 50580-407-04
CHILDREN'S TYLENOL SUSPENSION 4 OZ. VERY BERRY STRAWBERRY FLAVOR 50580-493-04
CHILDREN'S TYLENOL SUSPENSION 1 OZ. CHERRY BLAST FLAVOR - SAMPLE 50580-123-01
CHILDREN'S TYLENOL SUSPENSION 4 OZ. CHERRY BLAST FLAVOR - HOSPITAL 50580-123-03
CHILDREN'S TYLENOL PLUS SUSPENSIONS
CHILDREN'S TYLENOL PLUS SUSPENSION 4 OZ. COUGH & SORE THROAT CHERRY FLAVOR 50580-247-04
CHILDREN'S TYLENOL PLUS SUSPENSION 4 OZ. COUGH & RUNNY NOSE CHERRY FLAVOR 50580-249-04
CHILDREN'S TYLENOL PLUS DYE-FREE SUSPENSION 4 OZ. COLD & STUFFY NOSE GRAPE FLAVOR 50580-253-04
CHILDREN'S TYLENOL PLUS DYE-FREE SUSPENSION 4 OZ. COLD & COUGH GRAPE FLAVOR 50580-254-04
CHILDREN'S TYLENOL PLUS DYE-FREE SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR 50580-255-04
CHILDREN'S TYLENOL PLUS SUSPENSION 4 OZ. FLU BUBBLEGUM FLAVOR 50580-386-04
CHILDREN'S TYLENOL PLUS SUSPENSION 4 OZ. COLD GRAPE FLAVOR 50580-387-04
CHILDREN'S TYLENOL PLUS SUSPENSION 4 OZ. COLD & ALLERGY BUBBLEGUM FLAVOR 50580-390-04
CHILDREN'S TYLENOL PLUS SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR 50580-391-04
MOTRIN INFANTS' DROPS
CONCENTRATED MOTRIN INFANTS' DROPS 1 OZ. BERRY DYE FREE 50580-198-01
CONCENTRATED MOTRIN INFANTS' DROPS 0.5 OZ. BERRY DYE FREE 50580-198-15
CONCENTRATED MOTRIN INFANTS' DROPS 0.5 OZ. BERRY FLAVOR* 50580-100-15
CHILDREN'S MOTRIN SUSPENSIONS
CHILDREN'S MOTRIN SUSPENSION 4 OZ. BERRY DYE FREE 50580-184-04
CHILDREN'S MOTRIN SUSPENSION 2 OZ. BERRY FLAVOR 50580-601-02
CHILDREN'S MOTRIN SUSPENSION 4 OZ. BERRY FLAVOR 50580-601-04
CHILDREN'S MOTRIN SUSPENSION 4 OZ. TROPICAL PUNCH FLAVOR 50580-215-04
CHILDREN'S MOTRIN SUSPENSION 4 OZ. GRAPE FLAVOR 50580-603-04
CHILDREN'S MOTRIN SUSPENSION 4 OZ. BUBBLEGUM FLAVOR 50580-604-04
CHILDREN'S MOTRIN SUSPENSION 1 OZ. GRAPE SAMPLE 50580-603-01
CHILDREN'S MOTRIN SUSPENSION 1 OZ. BUBBLEGUM SAMPLE 50580-604-01
CHILDREN'S MOTRIN SUSPENSION 1 OZ. BERRY SAMPLE 50580-601-01
CHILDREN'S MOTRIN SUSPENSION 4 OZ. BERRY HOSPITAL 50580-601-50
CHILDREN'S MOTRIN SUSPENSION 4 OZ. COLD BERRY FLAVOR 50580-902-04
CHILDREN'S ZYRTEC LIQUIDS IN BOTTLES
CHILDREN'S ZYRTEC 4 OZ. BUBBLEGUM SYRUP 50580-721-04
CHILDREN'S ZYRTEC DYE FREE 4 OZ. GRAPE SYRUP 50580-730-04
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 50580-721-15
CHILDREN'S ZYRTEC SUGAR-FREE DYE-FREE 2 X 4 OZ. BUBBLEGUM LIQUID 50580-721-08
CHILDREN'S BENADRYL ALLERGY LIQUIDS IN BOTTLES
CHILDREN'S BENADRYL ALLERGY 4 OZ. BUBBLEGUM FLAVORED LIQUID 50580-535-04
*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.

SOURCES:

McNeil Consumer Healthcare web site.

FDA web site.

News release, FDA.

News release, McNeil Consumer Healthcare.

Layton, L. Washington Post, online, May 2, 2010.

© 2010 WebMD, LLC. All rights reserved.



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