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Recall of Immune Globulin Intravenous (Human), Gammar-P I.V., 10 gm |
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DATE RECALL INITIATED: April 1, 2004 LOT NUMBER / EXPIRATION DATE:
A639110 10/23/2006 MANUFACTURER:
Aventis Behring L.L.C. REASON: 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.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
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