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Octagam [Immune Globulin Intravenous (human)] 5 & #37; Liquid Preparation: Market Withdrawal - Risk of Thromboembolic Events

Wed, 08/25/2010 - 7:33am
U.S. Food & Drug Administration

AUDIENCE: Risk Manager, Hematology, Pharmacy

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BACKGROUND: There were 9 thromboembolic events potentially associated with 7 of the lots that are being withdrawn from the market.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.

[08/24/2010 - Recall Notice - FDA]

    

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