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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Market Withdrawal of Immune Globulin Intravenous (Human), GAMMAGARD S/D, 10 gm-Baxter SA

DATE RECALL INITIATED:

June 24, 2004

 

LOT NUMBER / EXPIRATION DATE:

 

LE08D030AA 3/30/2006

 

MANUFACTURER:

 

Baxter SA
Lessines, Belgium

REASON:

 

There has been an increased frequency of adverse event reports of allergic reactions associated with this lot. Although none of these reactions have been life threatening, two reported reactions involved the airway, and all reactions required medical intervention. The firm requests the use of this lot be immediately discontinued, and the affected product be returned to the manufacturer.

 

 

Contact FDA

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(240) 402-8010
Consumer Affairs Branch (CBER)

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Food and Drug Administration

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Silver Spring, MD 20993-0002