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:
| PRODUCTS | NDC Number |
| 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 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 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 |
| 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.
For more information about the recall, visit Tylenol’s web site here.
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