DATE RECALL INITIATED:
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.
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.
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