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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