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DATE RECALL INITIATED:
July 18, 2001
PRODUCT / LOT NUMBER / EXPIRATION DATE:
Albumin (Human) USP, 5% Solution, Buminate 5%, 250 mL
29240641AA 12/2/2002
MANUFACTURER:
Baxter Healthcare Corporation
Glendale, CA
REASON:
Subsequent to release of this product Baxter performed a non-required PCR test of the plasma manufacturing pool from which this product was derived. A low-level positive PCR test result for HIV-2 was obtained for the fourth centrifugation run of the plasma manufacturing pool. The manufacturing process includes steps for viral inactivation. No adverse events associated with this specific lot have been reported.
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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