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
|
|
TYLENOL 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.
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