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Tylenol Children's Products Recall

Posted by Jane Akre
Thursday, September 24, 2009 4:11 PM EST
Category: Protecting Your Family
Tags: Tylenol, Children's Tylenol, Children's Cold Medications, McNeil Consumer Healthcare

Some Children's Tylenol products are pulled from store shelves because of a bacterial contamination.

Tylenol Recall

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IMAGE SOURCE: Tylenol Web site/ children

You have to look for the information on this recall.

Checking the Tylenol Web site under Children’s Tylenol News is a list of liquid products for kids that are coming off store shelves.

The notice begins: "You may have heard that McNeil Consumer Healthcare (the makers of Tylenol) is voluntarily recalling certain lots of Children's and Infants' Tylenol liquid products that were manufactured between April, 2008 and June, 2008 in consultation with the U.S. Food and Drug Administration (FDA)."

The brands include Children’s Tylenol Suspension 4 ounce Strawberry, Children’s Tylenol Pediatric Suspension 1 ounce Cherry, and Infant’s Tylenol Suspension Drops ½ ounce Grape.

The company says one of the inactive ingredients tested positive for a gram-negative bacteria, Burkholderia cepacia or B. cepacia. However none of the bacteria was found in the finished product. The bacteria come from soil, according to the Centers for Disease Control and Prevention (CDC), and is responsible for some antibiotic resistant hospital infections.

McNeil Consumer Healthcare is advising parents who have given the Tylenol product to their children to contact their healthcare provider. The products in question were made between April and June 2008.

You are asked to contact Customer Care at 1-800-962-5357 if you have the affected product to receive a new one. The company also provides another number for its Medical Affairs Department 1-800-962-5357.

The lot numbers of the products are contained on the Web site.

For Healthcare Professionals link on the web site posts a letter:

“The company has implemented this recall because examination of bulk raw material detected that one of the inactive ingredients did not meet internal testing requirements.Specifically, the gram-negative bacteria Burkholderia cepacia (B. cepacia) was detected. The portion of raw material in which the bacteria was found was isolated and was not used in the production of any finished product. However, it was decided, as a precaution, to recall all product that utilized any of the raw material manufactured at the same time as the raw material that tested positive for the bacteria. Please note: No bacteria has been detected in finished product and the finished product has met all specifications.”

There are 21 products in all that are affected including:

Here's US Recall News' list of 21 affected products:

Children’s Tylenol Plus Cold MS Suspension 4 oz. Grape
Children’s Tylenol Suspension 4 oz. Grape
Children’s Tylenol Suspension 4 oz. Strawberry
Children’s Tylenol Suspension 4 oz. Bubble Gum
Infants’ Tylenol Suspension 1/2 oz. Cherry
Infants’ Tylenol Grape Suspension Drops 1/4 oz.
Children’s Tylenol Dye Free Suspension 4 oz. Cherry
Children’s Tylenol Suspension 4 oz. Cherry
Children’s Tylenol Plus Cough & Runny Nose 4 oz. Cherry
Infants’ Tylenol Suspension Drops 1/2 oz. Grape
Children’s Tylenol Plus Flu 4 oz. Bubble Gum
Children’s Tylenol Plus Cold Suspension 4 oz. Grape
Children’s Tylenol Plus Cough/ST Suspension 4 oz. Cherry
Infants’ Tylenol Suspension Drops 1 oz. Grape
Infants’ Tylenol Dye Free Suspension 1 oz. Cherry
Children’s Tylenol Pediatric Suspension 1 oz. Cherry
Infants’ Tylenol Suspension Drops 1 oz. Cherry
Children’s Tylenol Plus Cold/Allergy 4 oz. Bubble Gum
Infants’ Tylenol Grape Suspension Drops H/G 1/2 oz.
Infants’ Tylenol Drops 1 oz. Grape
Children’s Tylenol Suspension 4 oz. Cherry, Hospital Govt. #


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