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).
McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children. 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. While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use.
The company is conducting a comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before new manufacturing is initiated at the plant where the recalled products were made.
Consumers can contact the company at 1-888-222-6036 and also at www.mcneilproductrecall.com. Parents and caregivers who are not sure about alternative pediatric health treatment options should talk to their doctor or pharmacist and are reminded to never give drug products to infants and children that are not intended for those age groups as this could result in serious harm
For additional information, including affected NDC numbers, consumers should visit our website www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch1.|
McNeil Consumer Healthcare, Division of McNeil-PPC, Inc. markets a broad range of well-known OTC 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
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