Http://www.fda.gov/safety/recalls/ucm210443.htm

McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and .
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FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children’s Products
FOR IMMEDIATE RELEASE - 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).
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 1. 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/medwatch 2.| McNeil Consumer Healthcare, Division of McNeil-PPC, Inc. markets a broad range of well-known OTC products. PRODUCTS
NDC Number
CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. GRAPE FLAVOR CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE FLAVOR* CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. CHERRY DYE FREE CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. CHERRY FLAVOR CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. CHERRY FLAVOR CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE - HOSPITAL CONCENTRATED TYLENOL® INFANTS’ DROPS 0.25 OZ. GRAPE - SAMPLE CHILDREN’S TYLENOL® SUSPENSION 2 OZ. CHERRY BLAST FLAVOR CHILDREN’S TYLENOL® SUSPENSION 4 OZ. CHERRY BLAST FLAVOR CHILDREN’S TYLENOL® DYE-FREE SUSPENSION 4 OZ. CHERRY FLAVOR CHILDREN’S TYLENOL® SUSPENSION 4 OZ. GRAPE SPLASH CHILDREN’S TYLENOL® SUSPENSION 4 OZ. BUBBLEGUM FLAVOR CHILDREN’S TYLENOL® SUSPENSION 4 OZ. VERY BERRY STRAWBERRY FLAVOR CHILDREN’S TYLENOL® SUSPENSION 1 OZ. CHERRY BLAST FLAVOR – SAMPLE CHILDREN’S TYLENOL® SUSPENSION 4 OZ. CHERRY BLAST FLAVOR – HOSPITAL CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COUGH & SORE THROAT CHERRY FLAVOR CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COUGH & RUNNY NOSE CHERRY FLAVOR CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. COLD & STUFFY NOSE GRAPE FLAVOR CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. COLD & COUGH GRAPE FLAVOR CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR http://www.fda.gov/Safety/Recalls/ucm210443.htm McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and .
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. FLU BUBBLEGUM FLAVOR CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COLD GRAPE FLAVOR CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COLD & ALLERGY BUBBLEGUM FLAVOR CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR CONCENTRATED MOTRIN® INFANTS’ DROPS 1 OZ. BERRY DYE FREE CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY DYE FREE CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY FLAVOR* CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY DYE FREE CHILDREN’S MOTRIN® SUSPENSION 2 OZ. BERRY FLAVOR CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY FLAVOR CHILDREN’S MOTRIN® SUSPENSION 4 OZ. TROPICAL PUNCH FLAVOR CHILDREN’S MOTRIN® SUSPENSION 4 OZ. GRAPE FLAVOR CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BUBBLEGUM FLAVOR CHILDREN’S MOTRIN® SUSPENSION 1 OZ. GRAPE SAMPLE CHILDREN’S MOTRIN® SUSPENSION 1 OZ. BUBBLEGUM SAMPLE CHILDREN’S MOTRIN® SUSPENSION 1 OZ. BERRY SAMPLE CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY HOSPITAL CHILDREN’S MOTRIN® SUSPENSION 4 OZ. COLD BERRY FLAVOR CHILDREN’S ZYRTEC® 4 OZ. BUBBLEGUM SYRUP CHILDREN’S ZYRTEC® DYE FREE 4 OZ. GRAPE SYRUP CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 0.5 OZ. GRAPE CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 0.5 OZ. BUBBLEGUM CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 2 X 4 OZ. BUBBLEGUM LIQUID CHILDREN'S BENADRYL® ALLERGY LIQUIDS IN BOTTLES CHILDREN'S BENADRYL® ALLERGY 4 OZ. BUBBLEGUM FLAVORED LIQUID * 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 RSS Feed for FDA Recalls Information 3 [what's this? 4] Links on this page:
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Source: http://www.hellenicamericanacademy.com/FDA_Recall1.pdf