Recall of Immune Globulin Intravenous (Human) 10% Solvent/Detergent Treated, Gamimune N
DATE RECALL INITIATED:
February 1, 2002
LOT NUMBER / EXPIRATION DATE
648X078 8/27/2004
MANUFACTURER:
Bayer Corporation
Clayton, NC
REASON:
The firm received four customer reports describing the presence of a white precipitate in the solution. The firm’s initial investigation has identified the precipitate as immunoglobulin (IgG)..
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: 4/4/2002
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