Tuesday, November 21, 2017
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Pharmaceutical Liability News: FDA announced recall of several kid’s OTC meds

Product liability lawyer alert—FDA announced product safety recall of some Tylenol®, Motrin®, Zyrtec®, and Benadryl® children's over-the-counter medications.

McNeil Consumer Healthcare announced a recall of possibly defective children’s over-the-counter medications.
Pharmaceutical Liability News: FDA announced recall of several kid’s OTC meds

// West Palm Beach, Florida, USA // Legal News Reporter // Justice Legal News Reporter
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: Legal News for Product Liability Lawyers.



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