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).
| 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® 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® 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 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





