VOLUNTARY RECALL ON TYLENOL

.....per an email that was sent to Mackey Family Practice

March 29, 2010


Dear Healthcare Professional:


I am writing to inform you that, in consultation with the U.S. Food and Drug Administration (FDA),

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is initiating two (2) voluntary recalls: One (1) voluntary recall on certain product lots of Children’s TYLENOL® (acetaminophen) and

Children’s ZYRTEC® syrup (cetirizine HCI), and one (1) voluntary recall on certain product lots of Infants’ TYLENOL® (acetaminophen), Infants’ MOTRIN® (ibuprofen) and Children’s ZYRTEC® Sugar-Free, Dye-Free Bubblegum syrup 15mL bottle physician samples (cetirizine HCl 1mg/mL oral solution antihistamine).

RECALL 1

This voluntary recall includes certain product lots of Children’s TYLENOL® (acetaminophen) and Children’s ZYRTEC® syrup (cetirizine HCI). The Company is initiating this recall at the wholesale and retail levels after determining that a small number of product bottles supplied from one of our external suppliers have specific areas where the bottle plastic is thinner than required by our standard specifications.

As of the date of the recall there had been no reports of adverse events caused by the “thin-walled” bottle defect. The possibility of serious adverse events arising from the use of the product packaged in these bottles is remote, however, as a precaution we are initiating a voluntary recall at the warehouse and retail level for the affected lots. We are initiating the recall because the product may not maintain stability over time due to increased light exposure once the bottle is removed from the outer carton. See TylenolProfessional.com or ZyrtecProfessional.com for a Full Product Recall list.




RECALL 2

The second recall is also a voluntary recall on certain product lots of Infants’ TYLENOL® (acetaminophen), Infants’ MOTRIN® (ibuprofen), and Children’s ZYRTEC® Sugar-Free, Dye-Free Bubblegum syrup 15mL bottle physician samples (cetirizine HCI 1mg/mL oral solution antihistamine) distributed in the United States. The Company is initiating the recall at the wholesale level because the potential exists for the product lot number and/or expiration date printed on the bottle to become illegible as a result of consumer handling over the life of the product. To date there have been no reports of adverse events caused by this labeling issue. There are no indications that the absence of these lot numbers and expiration dates will cause adverse events. See TylenolProfessional.com or ZyrtecProfessional.com for a Full Product Recall list.


These are not consumer level recalls. However, patients with general questions should call our

Consumer Care Center at 1-888-543-8255 (available Monday-Friday 8 a.m. to 8 p.m. Eastern Time).

If you have any questions yourself, please call our Medical Affairs Department at 1-866-948-6883 (available Monday-Friday 9 a.m - 4:30 p.m. Eastern Time) or visit our dedicated Web sites for Healthcare Professionals at TylenolProfessional.com or ZyrtecProfessional.com.

Sincerely,



Edwin K. Kuffner, MD

Vice President, Medical Affairs

McNeil Consumer Healthcare