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July 25, 2007

Humate-P® Package Notification

Subject: Transfer set packaged with Humate-P® [Antihemophilic Factor / von Willebrand Factor Complex (Human)]

Dear Humate-P® User:

CSL Behring L.L.C. has identified an incidence of small holes in the blister packaging of the transfer set that is included in the Humate-P package. This finding affects our ability to ensure the safety of the transfer set. As a precaution, because of our commitment to patients, we are notifying all customers, users of Humate-P, and the U.S. Food and Drug Administration of our intentions to provide a replacement transfer set.

If you are in possession of Humate-P, please contact your product provider (homecare companies, hemophilia treatment centers, specialty pharmacies, distributors, hospitals, et.al) to obtain a replacement transfer device (Mix2Vial™). CSL Behring is making available the alternate transfer device (Mix2Vial) for all providers to replace the current transfer set.

Important note: There is nothing wrong with the Humate-P product or the diluent provided within the package. This is NOT a product integrity or safety issue. Rather, there is a potential safety issue with the transfer device. We have received no reports of a problem associated with a patient receiving Humate-P prepared with this transfer set. This is a theoretical risk only.

This notice pertains only to the transfer set that was packaged with Humate-P. It is important to note that there is no problem with the Humate-P product or diluent. THERE IS NO NEED TO RETURN ANY HUMATE-P® VIALS TO YOUR PROVIDER.

If you should have questions regarding this letter, please contact:

  • Natalie Thoma, R.Ph. or her associates at CSL Behring Consumer Affairs: 1-(888)-508-6978

In the event of an emergency (when additional shipment of Humate-P is required -such as surgery): the treating physician should contact Medical Affairs (800-504-5434) for authorization to release product for it to be shipped.

Thank you for your cooperation in this matter.

Sincerely,

Garrett E. Bergman, MD
Sr. Director, Medical Affairs