DATE RECALL INITIATED:
PRODUCT:
Albumin (Human) 25%, Albuminar, 100 mL
C934009 9/16/2007
C934110 10/5/2007
MANUFACTURER:
ZLB Behring L.L.C.
King of Prussia, PA
REASON:
Lots C934009 and C934110 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 two lots. As of this date, there are no technical complaints or adverse events reported against either lot. The firm is requesting that the use of these lots be immediately discontinued and that the product be returned to the manufacturer for credit.
Updated 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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