11/11/2011 - Baxter has recalled 6 lots of Gammagard (immune globulin intravenous [human]) 10% solution, 1 g size, due to the potential presence of metallic particles in some vials. The recall has been characterized as a precautionary measure after the glass vial supplier notified Baxter of the possibility of metallic particles partially embedded in the glass on the interior surface of the vial. The company requests customers immediately stop distributing the lots and quarantine any units still in inventory. Gammagard is indicated for treating primary immunodeficiency disorders associated with defects in humoral immunity.
Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting program online, by returning the postage-paid FDA form 3500 by mail (to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787) or fax (1-800-332-0178).
Primary immunodeficiencies are disorders in which part of the body's immune system is missing or does not function properly. To be considered a primary immunodeficiency, the cause of the immune deficiency must not be secondary in nature (i.e., caused by other disease, drug treatment, or environmental exposure to toxins). Most primary immunodeficiencies are genetic disorders; the majority are diagnosed in children under the age of one, although milder forms may not be recognized until adulthood. About 1 in 500 people is born with a primary immunodeficiency.
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