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U.S. Department of Health and Human Services

Safety

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Helixate (antihemophilic factor [recombinant])

Voluntary withdrawal of Helixate lot number 670H071E. This lot of Helixate 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 stored at 2-8° C. 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 this lot of Helixate.

[August 1, 2000 - Letter - Aventis Behring]