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DATE RECALL INITIATED:
February 19, 2003
LOT NUMBERS / EXPIRATION DATES:
CV02003A 03/18/2004
MANUFACTURER:
Alpha Therapeutic Corporation
Los Angeles, California
REASON:
The manufacturer found failed stability test results for Factor IX activity during storage at 30 degrees (o) Centigrade (C) for three months. Product that has been consistently stored under refrigeration, or at room temperature for less than two months remain acceptable. For those products that have been kept in refrigeration, establishments are instructed to contact the product supplier for a replacement package insert. This insert states that the product may be stored at room temperature not to exceed 30o C for 1 month. Establishments are also instructed to contact the product supplier for further instructions for those products that have been stored at room temperature for more than two months.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
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