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U.S. Department of Health and Human Services

Safety

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Haemophilus b Conjugate Vaccine (HibTITER)

Wyeth-Ayerst Pharmaceutical became aware that 5 cartons (each containing 80 multidose vials) of HibTITER 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.

[September 1, 2000 - Notice - FDA]