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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Plasma Protein Fraction, Plasmanate-Talecris Biotherapeutics

DATE RECALL INITIATED:

October 11, 2005

LOT NUMBER / EXPIRATION DATE:

Plasma Protein Fraction (Human) 5% USP, Plasmanate
26N39N1 9/20/2008

MANUFACTURER:

Talecris Biotherapeutics
Clayton, North Carolina

REASON:

Talecris Biotherapeutics, Inc. (formerly Bayer Corporation), is initiating a voluntary recall of one lot of Plasmanate, Plasma Protein Fraction (Human) 5% USP. A portion of lot 26N39N1 was processed during a period of time when the equipment used to secure an overseal on the bottle was noted to have fallen out of proper adjustment. Consignees are asked to return existing stock to Talecris Biotherapeutics.

 

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

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Suite 200N/HFM-47

Rockville, MD 20852-1448