Recall of Immune Globulin Intravenous (Human), Gammar-P I.V., 10 gm-Aventis Behring L.L.C.
DATE RECALL INITIATED:
April 1, 2004
LOT NUMBER / EXPIRATION DATE:
Aventis Behring L.L.C.
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.