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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:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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