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Urgent Recall of Immune Globulin Intravenous Product Due to Visible Contaminants


During a routine annual reserve inspection, visible particles were observed in Lot # 120016 of 100 mL sterile vials of BIVIGAM Immune Globulin Intravenous (Human), 10% Liquid. The expiration date on the 100 mL sterile vials is March 31, 2014. BIVIGAM Immune Globulin Intravenous (Human), 10% Liquid, is indicated for the treatment of primary humoral immunodeficiency. This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

 

The manufacturer, Biotest, is recalling Lot # 120016 from the market. Inspections of other lots of product have not shown the presence of visible particles; therefore, no other lots of product are affected by this recall. Consignees are asked to examine their stocks immediately to determine if they have any of Lot # 120016 on hand. If so, they are to discontinue distributing the lot and promptly return all vials to Biotest.

 

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