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Product Quarantine of Immune Globulin Intravenous (Human) Sought

Cheryl A. Thompson

Alpha Therapeutic Corporation is requesting that all stock of Immune Globulin Intravenous (Human), Venoglobulin-S, 10% solution with lot numbers GR9035A (expiration 04/04/2001) and GR9036A (expiration 04/06/2001) 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.