Withdrawal
Albumin (Human) 5%
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 The lot is being withdrawn due to internal audit findings at the plasma collection facility that provided the Source Plasma used to produce this product lot.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.
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.