sábado, 5 de junio de 2010

GammaGard Liquid, Immune Globulin Intravenous (Human)



GammaGard Liquid, Immune Globulin Intravenous (Human)
Audience: Allergy and Immunology, Pediatrics
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.
Read the complete MedWatch 2010 Safety summary, including a link to the Market Withdrawal Notice, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm214497.htm

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GammaGard Liquid, Immune Globulin Intravenous (Human)

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