Product Recall: Some Children's Tylenol

Filed under: In The News, Alerts & Recalls, Health

The makers of liquid Tylenol are recalling 18 of their medications used to treat infants and children.

The bacteria Burkholderia cepacia (B. cepacia) was detected in the raw material used to create the medications between April and June 2008, according to spokesman for McNeil Consumer Healthcare, which makes Tylenol. The corporate Web site stressed the health risk from the bacteria is minimal.

Company executives issued a public statement on their corporate Web site with a link to a letter specifically to health-care providers. The letter was signed by Dr. Edwin K. Kuffner, vice president of medical affairs.

Kuffner said the bacteria was found in an isolated amount in the raw material and was not used in the finished products. Furthermore, he said, ingesting the virus is "not known to be a route of transmission" for the bacteria.

However, he added, there have been reports of infections from contaminated products such as mouth washes and nasal sprays. These have reportedly caused severe medical problems, especially among people who have pulmonary disease, cystic fibrosis or compromised immune systems.

However, Kuffner stressed that the bacteria was never detected in any of the finished products and no incidents of contamination have been reported in the children's medications. Company executives also stressed they are ordering the recall of 57 lots of medication voluntarily after consultation with the Food and Drug Administration to maintain their rigorous safety standards.

Kuffner suggests any parents or caregivers who suspect they may have given the recalled products to children and now have health concerns should contact their physicians. Parents and caregivers can also call 800-962-5357 between 8 a.m. and 8 p.m. ET weekdays.

Look for the lot number on the bottom of the box that medication came in or a sticker surrounding the bottle.

Products being recalled include grape-flavored Children's Tylenol (4 ounce), grape-flavored Infants' Tylenol Suspension Drops (one-quarter ounce) and bubble gum-flavored Children's Tylenol Plus Cold/Allergy (4 ounce).

A complete list of the recall products and lot numbers are available by referring to the letter at the company's Web site.


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