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

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DATE RECALL INITIATED:

December 19, 2003

LOT NUMBER / EXPIRATION DATE

A631805   5/19/2006

MANUFACTURER:

Aventis Behring, LLC
Bradley, IL

REASON:

This lot exhibits an increased frequency of adverse event reports associated with allergic reactions. The adverse events received to date for this lot are principally hives and itching.

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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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