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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Market Withdrawal of GAMMAGARDLIQUID, Immune Globulin Intravenous (Human)

DATE WITHDRAWAL INITIATED:

May 27, 2010

PRODUCT / LOT NUMBER /EXPIRATION DATE:

GammaGard Liquid, Immune Globulin Intravenous (Human)

Lot Number

 Product Code NDC Number Expiration Date
LE12J370AB

1500185

 0944-2700-06 November 21, 2012
LE12J379AB

1500187

 0944-2700-05 November 29, 2012

MANUFACTURER:

Baxter BioScience
Westlake Village, California

REASON:

This voluntary market withdrawal is being conducted as a precautionary measure due to an increased number of adverse event reports of allergic reactions associated with these two lots. Customers are asked to complete the Urgent Market Withdrawal Instructions.

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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