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SafetyAlerts
January 15, 2002

Recall of Antihemophilic Factor (Recombinant), Helixate FS / Kogenate FS (Formulated with Sucrose)

Berkley, CA (SafetyAlerts) - The Food and Drug Administration (FDA) said that Bayer Corporation has recalled their Antihemophilic Factor (Recombinant), Helixate FS / Kogenate FS (Formulated with Sucrose).

TPRODUCT / LOT NUMBER / EXPIRATION DATE:

Helixate         FS 372J033C           9/4/2002
Kogenate       FS 372J009A           3/30/2002 (This lot was distributed by Bayer in Canada)

MANUFACTURER:

Bayer Corporation
Berkley, CA

REASON:

Potency testing following nine weeks storage at room temperature found that the lots fell below the minimum potency specification. The lots continued to meet potency requirements when continuously refrigerated. The recall applies only to vials that were not stored under continuous refrigeration
.

 
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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.