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Recall of Plasma Protein Fraction (Human), Plasmanate

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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.

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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.

 

Updated October 12, 2005
 
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