ISSUE: Octapharma USA Inc. initiated a voluntary market withdrawal of selected lots of Octagam [Immune Globulin Intravenous (human)] 5% Liquid Preparation as a result of an increased number of reported thromboembolic events, some of which were serious.
BACKGROUND: There were 9 thromboembolic events potentially associated with 7 of the lots that are being withdrawn from the market. Octagam is indicated for treatment of primary humoral immunodeficiency (PI), such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiencies. See FDA Recall Notice for listing of affected lots.
RECOMMENDATION: Customers are asked to immediately quarantine the use of affected lots and to contact Octapharma’s Customer Service Department to arrange for product return.