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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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:

 

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

 

MANUFACTURER:

 

Aventis Behring L.L.C.
Bradley, IL

 

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.

 

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002