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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Albumin (Human) 25 %, Albuminar (Updated)-ZLB Behring LLC

Information updated 9/22/2005

DATE RECALL INITIATED:

August 26 and 29, 2005

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

 

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