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2/27/2003

Firm Recalls Unrefrigerated Lot of Coagulation Factor IX

Cheryl A. Thompson

AlphaNine SD vials in lot CV02003A that have been stored at room temperature for two or more months are being recalled by Alpha Therapeutic Corp., according to an announcement today by the Food and Drug Administration (FDA).

Tests of lot CV02003A indicated that, when stored at 30 degrees C, the plasma-derived coagulation factor IX product was not stable for three months—a storage condition described as OK in the labeling dated September 2000. The lot has an expiration date of March 18, 2004.

According to FDA's announcement, AlphaNine SD vials that have been stored under refrigeration at all times or at room temperature for less than two months are usable. Persons or companies that have kept AlphaNine SD vials under refrigeration are supposed to contact the supplier of those vials for a new package insert. The new insert states that the product may be stored at room temperature (not exceeding 30 degrees C) for up to one month.

Persons or companies that have stored the product at room temperature for more than two months are supposed to contact the supplier of those vials for further instructions.