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Vaccines, Blood & Biologics

Withdrawal of Albumin (Human) 5 %-Talecris Biotherapeutics

DATE NOTIFICATION INITIATED:

April 30, 2008

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Plasbumin-5     Albumin (Human) 5%, USP

Lot Number: 26N9P21
Expiration Date: March 7, 2011

MANUFACTURER:

Talecris Biotherapeutics Clayton, North Carolina

REASON:

Talecris Biotherapeutics is initiating a Voluntary Withdrawal of one lot of Plasbumin-5, Albumin (Human) 5%, USP. The lot is being withdrawn due to internal audit findings at the plasma collection facility that provided the Source Plasma used to produce this product lot. These findings indicate inadequate documentation of storage and handling prior to shipment of the plasma to the Talecris manufacturing facility. No adverse events or product complaints have been reported or associated with the use of this lot.

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Food and Drug Administration

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Silver Spring, MD 20993-0002

Page Last Updated: 06/27/2013
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