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DATE QUARANTINE INITIATED:
June 11, 1999
PRODUCT / LOT NUMBER / EXPIRATION DATE:
Immune Globulin Intravenous (Human), Venoglobulin-S, 10% solution:
GR9035A 04/04/2001
GR9036A 04/06/2001
MANUFACTURER:
Alpha Therapeutic Corporation
Los Angeles, CA
REASON:
Alpha Therapeutic Corporation is requesting that all stock of the above mentioned lots be held in quarantine until further notice. This action is being taken because post-manufacturing visual inspection detected microbial contamination in a single vial from two other lots of Immune Globulin Intravenous. All products filled in the same area during the same time period passed sterility testing, including lots GR9035A and GR9036A. However, Alpha has determined that this cautionary quarantine is prudent to insure patient safety until their investigation is completed.
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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