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U.S. Department of Health and Human Services


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Kogenate (antihemophilic factor [recombinant])

Voluntary withdrawal of Kogenate lot numbers 670H071C and 670H076. This lot of Kogenate was tested for Factor VIII potency using a reagent known as FVIII-deficient plasma. During a routine quality assurance investigation of the testing procedure, Bayer learned that Lot 670H071 may not retain its labeled potency if held at room temperature (25° C) for 3 months. The product will remain stable if refrigerated. Further investigation has confirmed that the cause is not related to a stability issue with the product but is attributed to the reagent used during the initial testing. As of this date there have been no adverse events reported in association with these lots.

[July 27, 2000 - Letter - Bayer]