Two Lots of Human Immune Globulin IV Withdrawn Due to Reports of Allergic Reactions
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Two Lots of Human Immune Globulin IV Withdrawn Due to Reports of Allergic Reactions

ROCKVILLE, Md -- June 4, 2010 -- The US Food and Drug Administration (FDA) and Baxter BioScience are notifying healthcare professionals of a market withdrawal being conducted as a precautionary measure due to an increased number of adverse event reports of allergic reactions associated with 2 lots of human immune globulin intravenous (GammaGard Liquid).

Immune globulin intravenous (human) is indicated for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity.

The following lots are being withdrawn:

· Lot Number: LE12J370AB/ Product Code: 1500185/ NDC Number: 0944-2700-06 /Expiration Date: November 21, 2012
· Lot Number: LE12J379AB/ Product Code: 1500187/ NDC Number: 0944-2700-05/ Expiration Date: November 29, 2012

Customers are asked to complete the Urgent Market Withdrawal Instructions.

SOURCE: US Food and Drug Administration

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