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GammaGard Liquid, Immune Globulin Intravenous (Human)

Fri, 06/04/2010 - 1:20pm
FDA MedWatch

Audience: Allergy and Immunology, Pediatrics

[Posted 06/04/2010]

ISSUE: Baxter BioScience and FDA notified 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 two lots of the product.

BACKGROUND: GammaGard Liquid is indicated for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity.

RECOMMENDATION: Customers are asked to contact Baxter BioScience for Urgent Market Withdrawal instructions. See the Market Withdrawal Notice for information on affected lots.

[06/03/2010 - Market Withdrawal Notice - FDA]

    

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