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UPDATE: New information about Children's Medicine Recall

UPDATE: New information about Children's Medicine Recall

by TERRI GRUCA / KVUE News

Bio | Email | Follow: @TerriG_KVUE

kvue.com

Posted on May 2, 2010 at 12:31 AM

Updated Wednesday, May 5 at 4:44 PM

Update: The Food and Drug Administration now says the dozens of children's medicines recalled over the weekend may have been contaminated by a bacteria.

This recall involves several different types of products from Children's Tylenol to Children's Motrin, Children's Zyrtec and Children's Benadryl. You'll find the complete list below.

According to McNeil Consumer Healthcare, a unit of Johnson & Johnson, some of these products may not meet required quality standards. The problems may affect the potency, purity or quality of the medicines. They are asking parents who have these medicines in their home to not administer them to their children.

The FDA says, “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.

If you have questions you can call 1-888-222-6036 or find more information at the company’s web site.

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.

The medicines involved in this recall are listed below:

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

 

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