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Recall of Immune Globulin Intravenous (Human) 10% Solvent/Detergent Treated, Gamimune N
DATE RECALL INITIATED: March 14, 2002 LOT NUMBER / EXPIRATION DATE 648X062 7/16/2004 MANUFACTURER:
Bayer Corporation 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..
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.
Last Updated: 3/15/2002 |