Information updated 9/22/2005
DATE RECALL INITIATED:
PRODUCT:
Albumin (Human) 25%, Albuminar, 100 mL
U.S. Distribution:
C934009 9/16/2007
C934110 10/5/2007
C805209 8/31/2007 (China)
C805309 9/24/2007 (China)
C934210 10/7/2007 (Japan)
C934310 10/14/2007 (Japan)
MANUFACTURER:
ZLB Behring L.L.C.
King of Prussia, PA
REASON:
The above listed lots are being recalled as a precautionary measure. One bottle of Albuminar in Japan has been found with a stopper defect that may allow product leakage. The same stopper batch as that used in Japan was also used on these lots. As of this date, there are no technical complaints or adverse events reported. The firm is requesting that the use of these lots be immediately discontinued and that the product be returned to the manufacturer for credit.
Previous information
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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