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Recall of Children’s Tylenol, Motrin, Zyrtec, and Benadryl

By AWHONN Editorial Staff

Recall of Children’s Tylenol, Motrin, Zyrtec, and Benadryl

April 30, 2010—A voluntary recall of 43 child and infant liquid formulations of Tylenol, Motrin, Zrytec, and Benadryl by McNeil, a division of Johnson & Johnson, due to manufacturing defects. There have been no injuries or deaths reported. The voluntary recall follows an April 19 FDA inspection of a McNeil plant in Fort Washington, PA that uncovered manufacturing deficiencies. Some of the products may contain a higher concentration of active ingredient than is specified, others may contain inactive ingredients that may not meet testing requirements, and some may contain tiny particles.

If children who have taken the recalled products have unusual symptoms, parents are urged to contact a healthcare professional. Parents should not give children adult formulations 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 is likely to be very high. Recalled products were distributed in the U.S., Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait.

Complete list of the recalled products:

PRODUCTSNDC Number
CONCENTRATED TYLENOL INFANTS’ DROPS 1 OZ. GRAPE FLAVOR50580-144-01
CONCENTRATED TYLENOL INFANTS’ DROPS 0.5 OZ. GRAPE FLAVOR*50580-144-15
CONCENTRATED TYLENOL INFANTS’ DROPS 1 OZ. CHERRY DYE FREE50580-167-01
CONCENTRATED TYLENOL INFANTS’ DROPS 0.5 OZ. CHERRY FLAVOR50580-143-15
CONCENTRATED TYLENOL INFANTS’ DROPS 1 OZ. CHERRY FLAVOR50580-143-30
CONCENTRATED TYLENOL INFANTS’ DROPS 0.5 OZ. GRAPE – HOSPITAL50580-144-18
CONCENTRATED TYLENOL INFANTS’ DROPS 0.25 OZ. GRAPE – SAMPLE50580-144-40
CHILDREN’S TYLENOL SUSPENSION 2 OZ. CHERRY BLAST FLAVOR50580-123-02
CHILDREN’S TYLENOL SUSPENSION 4 OZ. CHERRY BLAST FLAVOR50580-123-04
CHILDREN’S TYLENOL DYE-FREE SUSPENSION 4 OZ. CHERRY FLAVOR50580-166-04
CHILDREN’S TYLENOL SUSPENSION 4 OZ. GRAPE SPLASH50580-296-04
CHILDREN’S TYLENOL SUSPENSION 4 OZ. BUBBLEGUM FLAVOR50580-407-04
CHILDREN’S TYLENOL SUSPENSION 4 OZ. VERY BERRY STRAWBERRY FLAVOR50580-493-04
CHILDREN’S TYLENOL SUSPENSION 1 OZ. CHERRY BLAST FLAVOR – SAMPLE50580-123-01
CHILDREN’S TYLENOL SUSPENSION 4 OZ. CHERRY BLAST FLAVOR – HOSPITAL50580-123-03
CHILDREN’S TYLENOL PLUS SUSPENSION 4 OZ. COUGH & SORE THROAT CHERRY FLAVOR50580-247-04
CHILDREN’S TYLENOL PLUS SUSPENSION 4 OZ. COUGH & RUNNY NOSE CHERRY FLAVOR50580-249-04
CHILDREN’S TYLENOL PLUS DYE-FREE SUSPENSION 4 OZ. COLD & STUFFY NOSE GRAPE FLAVOR50580-253-04
CHILDREN’S TYLENOL PLUS DYE-FREE SUSPENSION 4 OZ. COLD & COUGH GRAPE FLAVOR50580-254-04
CHILDREN’S TYLENOL PLUS DYE-FREE SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR50580-255-04
CHILDREN’S TYLENOL PLUS SUSPENSION 4 OZ. FLU BUBBLEGUM FLAVOR50580-386-04
CHILDREN’S TYLENOL PLUS SUSPENSION 4 OZ. COLD GRAPE FLAVOR50580-387-04
CHILDREN’S TYLENOL PLUS SUSPENSION 4 OZ. COLD & ALLERGY BUBBLEGUM FLAVOR50580-390-04
CHILDREN’S TYLENOL PLUS SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR50580-391-04
CONCENTRATED MOTRIN INFANTS’ DROPS 1 OZ. BERRY DYE FREE50580-198-01
CONCENTRATED MOTRIN INFANTS’ DROPS 0.5 OZ. BERRY DYE FREE50580-198-15
CONCENTRATED MOTRIN INFANTS’ DROPS 0.5 OZ. BERRY FLAVOR*50580-100-15
CHILDREN’S MOTRIN SUSPENSION 4 OZ. BERRY DYE FREE50580-184-04
CHILDREN’S MOTRIN SUSPENSION 2 OZ. BERRY FLAVOR50580-601-02
CHILDREN’S MOTRIN SUSPENSION 4 OZ. BERRY FLAVOR50580-601-04
CHILDREN’S MOTRIN SUSPENSION 4 OZ. TROPICAL PUNCH FLAVOR50580-215-04
CHILDREN’S MOTRIN SUSPENSION 4 OZ. GRAPE FLAVOR50580-603-04
CHILDREN’S MOTRIN SUSPENSION 4 OZ. BUBBLEGUM FLAVOR50580-604-04
CHILDREN’S MOTRIN SUSPENSION 1 OZ. GRAPE SAMPLE50580-603-01
CHILDREN’S MOTRIN SUSPENSION 1 OZ. BUBBLEGUM SAMPLE50580-604-01
CHILDREN’S MOTRIN SUSPENSION 1 OZ. BERRY SAMPLE50580-601-01
CHILDREN’S MOTRIN SUSPENSION 4 OZ. BERRY HOSPITAL50580-601-50
CHILDREN’S MOTRIN SUSPENSION 4 OZ. COLD BERRY FLAVOR50580-902-04
CHILDREN’S ZYRTEC 4 OZ. BUBBLEGUM SYRUP50580-721-04
CHILDREN’S ZYRTEC DYE FREE 4 OZ. GRAPE SYRUP50580-730-04
CHILDREN’S ZYRTEC SUGAR-FREE DYE-FREE 0.5 OZ. GRAPE50580-730-15
CHILDREN’S ZYRTEC SUGAR-FREE DYE-FREE 0.5 OZ. BUBBLEGUM50580-721-15
CHILDREN’S ZYRTEC SUGAR-FREE DYE-FREE 2 X 4 OZ. BUBBLEGUM LIQUID50580-721-08
CHILDREN’S BENADRYL ALLERGY 4 OZ. BUBBLEGUM FLAVORED LIQUID50580-535-04

*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.

For more information about the recall, visit Tylenol’s web site here.


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