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Vaccines, Blood & Biologics

Recall of Immune Globulin Intravenous (Human), Gammar-P I.V., 10 gm-Aventis Behring L.L.C.



April 1, 2004




A639110 10/23/2006
A639210 10/23/2006




Aventis Behring L.L.C.
Bradley, IL



These lots exhibit an increased frequency of non-serious, labeled adverse events associated with allergic reactions. The adverse events received to date for these lots are principally hives. One case of angioedema was reported. The firm is requesting that the use of these lots be immediately discontinued and that the product be returned to the manufacturer for credit.


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Food and Drug Administration

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Silver Spring, MD 20993-0002

Page Last Updated: 06/27/2013
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