• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

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 The lot is being withdrawn due to internal audit findings at the plasma collection facility that provided the Source Plasma used to produce this product lot.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.

 

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