05/03/2010 // West Palm Beach, Florida, USA // Sandra Quinlan // Sandra Quinlan

Legal News for Product Liability Attorneys. McNeil Consumer Healthcare announced a massive recall of possibly defective children’s over-the-counter medications.

Fort Washington, PA—McNeil Consumer Healthcare, in cooperation with the U.S. Food and Drug Administration (FDA), has issued a voluntary recall of all non-expired lots of certain over-the-counter (OTC) Children’s and Infants’ liquid Tylenol®, Motrin®, Zyrtec®, and Benadryl® 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. The FDA announced the pharmaceutical recall on Friday, April 30, 2010.

While no injuries, illnesses or adverse medical events have been reported in connection with the product safety recall, McNeil Consumer Healthcare issued the recall as a safety precaution and urges all consumers to discontinue use of all affected over-the-counter children’s medications. Consumers have also been warned not to administer infants or children any medications that are not specifically made for their age groups, for this could cause potential health hazards.

According to the FDA, “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… 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.”

Products affected by the recall include the following:

• TYLENOL® INFANTS’ DROPS

CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. GRAPE FLAVOR

NDC #: 50580-144-01

CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE FLAVOR*

NDC #: 50580-144-15

CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. CHERRY DYE FREE

NDC #: 50580-167-01

CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. CHERRY FLAVOR

NDC #: 50580-143-15

CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. CHERRY FLAVOR

NDC #: 50580-143-30

CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE – HOSPITAL

NDC #: 50580-144-18

CONCENTRATED TYLENOL® INFANTS’ DROPS 0.25 OZ. GRAPE – SAMPLE

NDC #: 50580-144-40

• CHILDREN’S TYLENOL® SUSPENSIONS

CHILDREN’S TYLENOL® SUSPENSION 2 OZ. CHERRY BLAST FLAVOR

NDC #: 50580-123-02

CHILDREN’S TYLENOL® SUSPENSION 4 OZ. CHERRY BLAST FLAVOR

NDC #: 50580-123-04

CHILDREN’S TYLENOL® DYE-FREE SUSPENSION 4 OZ. CHERRY FLAVOR

NDC #: 50580-166-04

CHILDREN’S TYLENOL® SUSPENSION 4 OZ. GRAPE SPLASH

NDC #: 50580-296-04

CHILDREN’S TYLENOL® SUSPENSION 4 OZ. BUBBLEGUM FLAVOR

NDC #: 50580-407-04

CHILDREN’S TYLENOL® SUSPENSION 4 OZ. VERY BERRY STRAWBERRY FLAVOR

NDC #: 50580-493-04

CHILDREN’S TYLENOL® SUSPENSION 1 OZ. CHERRY BLAST FLAVOR – SAMPLE

NDC #: 50580-123-01

CHILDREN’S TYLENOL® SUSPENSION 4 OZ. CHERRY BLAST FLAVOR – HOSPITAL

NDC #: 50580-123-03

• CHILDREN’S TYLENOL® PLUS SUSPENSIONS

CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COUGH & SORE THROAT CHERRY FLAVOR

NDC #: 50580-247-04

CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COUGH & RUNNY NOSE CHERRY FLAVOR

NDC #: 50580-249-04

CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. COLD & STUFFY NOSE GRAPE FLAVOR

NDC #: 50580-253-04

CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. COLD & COUGH GRAPE FLAVOR

NDC #: 50580-254-04

CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR

NDC #: 50580-255-04

CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. FLU BUBBLEGUM FLAVOR

NDC #: 50580-386-04

CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COLD GRAPE FLAVOR

NDC #: 50580-387-04

CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COLD & ALLERGY BUBBLEGUM FLAVOR

NDC #: 50580-390-04

CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR

NDC #: 50580-391-04

• MOTRIN® INFANTS’ DROPS

CONCENTRATED MOTRIN® INFANTS’ DROPS 1 OZ. BERRY DYE FREE

NDC #: 50580-198-01

CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY DYE FREE

NDC #: 50580-198-15

CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY FLAVOR*

NDC #: 50580-100-15

• CHILDREN’S MOTRIN® SUSPENSIONS

CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY DYE FREE

NDC #: 50580-184-04

CHILDREN’S MOTRIN® SUSPENSION 2 OZ. BERRY FLAVOR

NDC #: 50580-601-02

CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY FLAVOR

NDC #: 50580-601-04

CHILDREN’S MOTRIN® SUSPENSION 4 OZ. TROPICAL PUNCH FLAVOR

NDC #: 50580-215-04

CHILDREN’S MOTRIN® SUSPENSION 4 OZ. GRAPE FLAVOR

NDC #: 50580-603-04

CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BUBBLEGUM FLAVOR

NDC #: 50580-604-04

CHILDREN’S MOTRIN® SUSPENSION 1 OZ. GRAPE SAMPLE

NDC #: 50580-603-01

CHILDREN’S MOTRIN® SUSPENSION 1 OZ. BUBBLEGUM SAMPLE

NDC #: 50580-604-01

CHILDREN’S MOTRIN® SUSPENSION 1 OZ. BERRY SAMPLE

NDC #: 50580-601-01

CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY HOSPITAL

NDC #: 50580-601-50

CHILDREN’S MOTRIN® SUSPENSION 4 OZ. COLD BERRY FLAVOR

NDC #: 50580-902-04

• CHILDREN’S ZYRTEC® LIQUIDS IN BOTTLES

CHILDREN’S ZYRTEC® 4 OZ. BUBBLEGUM SYRUP

NDC #: 50580-721-04

CHILDREN’S ZYRTEC® DYE FREE 4 OZ. GRAPE SYRUP

NDC #: 50580-730-04

CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 0.5 OZ. GRAPE

NDC #: NDC #: 50580-730-15

CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 0.5 OZ. BUBBLEGUM

NDC #: 50580-721-15

CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 2 X 4 OZ. BUBBLEGUM LIQUID

NDC #: 50580-721-08

• CHILDREN’S BENADRYL® ALLERGY LIQUIDS IN BOTTLES

CHILDREN’S BENADRYL® ALLERGY 4 OZ. BUBBLEGUM FLAVORED LIQUID

NDC #: 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

Consumers who have purchased any of the OTC products listed above are advised to cease use of the products. For additional information concerning the recall, consumers may contact McNeil Consumer Healthcare at (888) 222-6036 Monday through Friday from 8 a.m. to 10 p.m. ET or Saturday and Sunday from 9 a.m. to 5 p.m. ET. Consumers may also visit the company’s Web site at www.McNeilProductRecall.com.

To report any adverse events with regard to the recalled products, consumers are urged to contact the FDA’s MedWatch Program via 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.

Legal News Reporter: Sandra Quinlan- Legal News for Product Liability Lawyers.

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Url: http://sandra.visionsmartnews.com/fda-announced-recall-of-several-kids-otc-meds_139.html

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