The Food and Drug Administration has announced a voluntary manufacturer withdrawal of all lots of Octagam (an intravenous human normal immunoglobulin solution), effective immediately.
The action comes in response to reports of thromboembolic events associated with the use of Octagam (manufactured by Octapharma USA) and follows an Aug. 20 recall of selected lots of the drug.
Octagam is indicated for treatment of primary humoral immunodeficiency (such as congenital agammaglobulinemia), common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
Octapharma received no further reports of thromboembolic events since the recall of selected lots but has withdrawn the drug until the cause of the events can be determined and the problem corrected.
Customers are being asked to immediately quarantine their supply of Octagam and to contact Octapharma’s customer service department by telephone at 866-766-4860 or by e-mail at uscustomerservice@octapharma.com to arrange for product return.