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Vaccines, Blood & Biologics

Market Withdrawal of Immune Globulin Intravenous (Human), GAMMAGARD S/D, 10 gm-Baxter SA


June 24, 2004




LE08D030AA 3/30/2006




Baxter SA
Lessines, Belgium



There has been an increased frequency of adverse event reports of allergic reactions associated with this lot. Although none of these reactions have been life threatening, two reported reactions involved the airway, and all reactions required medical intervention. The firm requests the use of this lot be immediately discontinued, and the affected product be returned to the manufacturer.


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