FindLaw Class Action and Mass Tort Center: Recalls: Food, Drugs and Medical Devices: Recall of Immune Globulin Intravenous (Human) 10% Solvent/Detergent Treated, Gamimune N
FindLaw Class Action and Mass Tort Center: Recalls: Food, Drugs and Medical Devices:
NEWS: U.S. Department of Health and Human Services
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
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..
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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