December 13, 1985
Medical Bulletin #34
Chapter Advisory #39
Factor IX Product Withdrawal Announced
On Friday, November 29, 1985, Hyland Therapeutics Division of Travenol Laboratories, Inc., initiated a voluntary market withdrawal of one lot of Factor IX Complex, PROPLEX (not heat treated) in the United States. The Withdrawal was based on identification of a donor who was confirmed as having AIDS. The lot number being withdrawn by Hyland and involves one donation from a single donor, who did not present symptoms until after his last donation.
Hyland Therapeutics Division has consulted with the National Hemophilia Foundation on this matter, and we have been assured that all efforts have been made to contact the points of distribution that may have distributed vials from this lot. The lot that is being voluntarily withdrawn has not been heat treated.
AND MOST IMPORTANT, DESPITE THE CONCERN THAT MAY BE RAISED BY THE WITHDRAWAL OF PLASMA PRODUCTS, THE NHF REAFFIRMS ITS RECOMMENDATION THAT PATIENTS MAINTAIN THE USE OF CONCENTRATE, OR CRYOPRECIPITATE AS PRESCRIBED BY THEIR PHYSICIANS. THE LIFE AND HEALTH OF HEMOPHILIACS DEPENDS UPON THE APPROPRIATE USE OF BLOOD PRODUCTS.
If you have any questions regarding this matter, they should be directed to your treating physician, Chapter Medical Advisory Board Chairman, NHF Medical and Scientific Advisory Council Regional Representative or the NHF.
The following lot of clotting factor withdrawn by Hyland Therapeutics Division (November 29, 1985( bears the following lot number:
|Product||Lot #||Expiration Date|
|Factor IX Complex||0581A123AA||April 10, 1986|
* * * * * *
Note: The National Hemophilia Foundation only provides withdrawal information for concentrates that have not been heat treated. NHF does not provide information concerning heat treated product associated with an AIDS donor unless specific information and a request to provide such notification is made by the manufacturer. This is in keeping with MASAC policy (April 26, 1985) which “no longer recommends that heat treated product be withdrawn.”