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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, ZLB Behring LLC

DATE RECALL INITIATED:

August 29, 2005

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

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448