September 18, 2009
Dear Healthcare Professional:
I am writing to inform you that, in consultation with the U.S. Food and Drug Administration (FDA), McNeil
Consumer Healthcare is voluntarily initiating a recall of certain lots of Children's and Infants' TYLENOL®
products that were manufactured between April 2008 and June 2008. The full list of recalled product lots is below.
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.
A review of the relevant published scientific literature regarding B. cepacia indicates that while ingestion of contaminated pharmaceutical product is not known to be a route of transmission of B. cepacia infection,
infection has been reported following the use of contaminated pharmaceutical products such as
mouthwashes and nasal sprays. Adverse health consequence of B. cepacia infections could be potentially
severe especially in high-risk patients, such as those with underlying pulmonary disease, cystic fibrosis or
compromised immune systems.
McNeil has conducted an assessment of post-marketing safety surveillance data and did not identify any
safety signals or batch-related safety concerns for Infants' and Children's TYLENOL® products over the
time period, starting with the introduction of these batches, in or around April 2008.
McNeil is advising parents and caregivers who have administered affected product to their child or infant
and have concerns to contact their healthcare providers. Parents and caregivers can find the lot numbers
on the bottom of the box containing the product and also on the sticker that surrounds the product bottle. If your patients determine that they have affected product, they can contact our Customer Care Center at 1-800-962-5357 and we will send them a coupon for a new bottle.
If you have any questions, please call our Medical Affairs Department at 1-800-962-5357 (available
Monday-Friday 8 a.m. to 8 p.m. Eastern Time).
Edwin K. Kuffner, MD
Vice President, Medical Affairs
McNeil Consumer Healthcare
For the original and a full list of recalls, CLICK HERE