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Recall of Immune Globulin Intravenous (Human) 10% Solvent/Detergent Treated, Gamimune N

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DATE RECALL INITIATED:

March 14, 2002

LOT NUMBER / EXPIRATION DATE

648X062 7/16/2004

MANUFACTURER:

Bayer Corporation
Clayton, NC

REASON:

The firm received one customer report describing the presence of a white precipitate in the solution. The firm's initial investigation of the returned vials has identified unexpectedly low protein concentration, elevated chloride and the presence of bacteria..

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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 March 15, 2002
 
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