McNeil Consumer Healthcare Reminds Consumers It Is Important to Check If Any of Their Pediatric Liquid Medicines

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is reminding parents and caregivers to check their infants’ and children’s forms of TYLENOL®, MOTRIN®, ZYRTEC® and BENADRYL® after the April 30, 2010 voluntary recall. Please note that this recall did not affect children’s solid dosage forms such as chewables McNeil Consumer Healthcare initiated the voluntary recall because some of these products did not meet required quality standards. The recall was not undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not to 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 reminds consumers who have purchased these recalled products to discontinue use. The company has conducted 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. McNeil encourages consumers to contact the company’s Consumer Care Center at 1-888-222-6036 or to visit www.mcneilproductrecall.com for more information on the recall, to receive a refund or coupon, and for information about proper disposal of recalled products. 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 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/medwatch 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 FLAVO 50580-390-04 CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. MULTI SYMPTOM GRAPE FLAVOR 50580-391-04 MOTRIN® INFANTS’ DROPS CONCENTRATED MOTRIN® INFANTS’ DROPS 1 OZ. BERRY DYE FREE 50580-198-01 CONCENTRATED MOTRIN® INFANTS’ DROPS 1 OZ. BERRY DYE FREE 50580-198-11 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® COLD SUSPENSIONS CHILDREN’S MOTRIN® SUSPENSION 4 OZ. COLD BERRY FLAVOR 50580-902-04 CHILDREN’S ZYRTEC® CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 4 OZ. BUBBLEGUM SYRUP 50580-721-04 CHILDREN’S ZYRTEC® SUGAR-FREE 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 X4OZ. BUBBLEGUM 50580-721-08 CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE PERFECT MEASURE GRAPE 50580-723-10 CHILDREN’s BENADRYL® ALLERGY LIQUIDS IN BOTTLES CHILDREN’s BENADRYL® ALLERGY 4 OZ. SUGAR-FREE DYE- 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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