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Two lots of GammaGard Liquid, a treatment used to treat primary immunodeficiency disorders, are being pulled from the market as a precautionary measure because of an increased number of adverse event reports of allergic reactions associated with two lots of the product. A market withdrawal is defined in federal regulations as an action taken by a firm to remove or correct a distributed product because of a problem. The action is not considered a recall.
Manufactured by Baxter BioScience, GammaGard Liquid is used to treat various immunodeficiences including congenital X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome and severe combined immunodeficiencies. These conditions are usually inherited, are caused by errors in the genes of the cells that make up the immune system, and have a wide range of symptoms that can range from mild to severe.
Individuals with immunodeficiencies are more likely to get infections, take longer to recover even with treatment, and have recurring infections. It is often seen early in a child’s life but can also occur in older children, teenagers and adults.
Customers are asked to contact Baxter BioScience for Urgent Market Withdrawal instructions. Any adverse events associated with this or any other medication should be reported to the FDA MedWatch Adverse Event Reporting System at www.FDA.gov/MedWatch.
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