McNeil Recalls Children's, Infants' Tylenol Products

McNeil Consumer Healthcare, in consultation with the FDA, has voluntarily recalled a total of 57 lots of more than 20 of its liquid children's and infants' Tylenol products because of potential bacterial contamination.

The Fort Washington, Pa.-based company said in a Sept. 18 letter to health care professionals (2-page PDF; About PDFs) that 21 different product types manufactured from April 2008 through June 2008 are affected. A list of recalled products and lot numbers is included in the letter.

McNeil said it implemented the recall after the gram-negative bacterium Burkholderia cepacia was detected during examination of bulk raw material associated with one of the products' inactive ingredients. The company said no bacteria were detected in any finished product.

"The portion of raw material in which the bacteria was found was isolated and was not used in the production of any finished product," the company said in its letter. "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."

The manufacturer also said B. cepacia infections could be potentially severe, especially in high-risk patients, such as those who have underlying pulmonary disease, cystic fibrosis or compromised immune systems.

McNeil is advising parents and caregivers who have given recalled product to their children and who have concerns to contact their physicians.

Lot numbers can be found on the bottom of product boxes and also on the labels that surround product bottles. Patients who have affected product can contact the company at (800) 962-5357, and McNeil will respond with a coupon for a new bottle.