Firm Initiated Recall of Haemophilus b Conjugate Vaccine (HibTITER^Ò)

http://www.fda.gov/cber/recalls/hibwye083000.htm

DATE RECALL INITIATED:

August 30, 2000

LOT NUMBERS / EXPIRATION DATES:

613803A, 1/2002
Shipper Control #471-912

MANUFACTURER:

Wyeth-Ayerst Pharmaceutical
Radnor, PA

REASON:

Wyeth-Ayerst Pharmaceutical became aware that 5 cartons (each containing 80 multidose vials) of HibTITER^Ò Haemophilus b Conjugate Vaccine, Lot 613803A, were shipped inappropriately, in that the product was shipped by airfreight without a documented freeze indicator. Wyeth-Ayerst Pharmaceutical has initiated a recall of vials in question from Lot 613803A and is arranging for replacement of the subject vaccine. The firm is not recommending revaccination of children who have previously received vaccine from Lot 613803A.

The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

Last Updated: 4/9/2002