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Gammagard FDA Alerts

The FDA Alert(s) below may be specifically about Gammagard or relate to a group or class of drugs which include Gammagard (immune globulin intravenous and subcutaneous).

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for immune globulin intravenous and subcutaneous

GammaGard Liquid, Immune Globulin Intravenous (Human)

Jun 4, 2010

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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