Medication Recall Advisory

TO:	DDS Regional Directors, STS Director, CTH Coordinators, Private Providers, CO Quality Management Personnel
FROM:	Daniel A. Micari, Director, Quality Management Services
DATE:	June 30, 2011
RE:	MEDICATION RECALL ADVISORY: Tylenol Extra Strength Caplets, 225 count bottles: Recall - Uncharacteristic Odor

Medication Recall Advisory

The US Food and Drug Administration noted on 6/29/2011 that the McNeil Consumer Healthcare is recalling one product lot of Tylenol Extra Strength Caplets, 225 count bottles, distributed in the U.S. The recall stems from a small number of odor reports, including musty, moldy odor. The uncharacteristic musty, moldy odor has been linked to the presence of trace amounts of a chemical known as 2,4,6-tribromoanisole (TBA). While not considered to be toxic, TBA can generate an offensive odor and has been associated with temporary and non-serious gastrointestinal symptoms.

For further information, please view the below web site:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm261509.htm

Please ensure those responsible are aware of this medication recall advisory. Also review your supplies to determine whether or not the identified products are present. If the identified products are present, address appropriately.