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Biotest has voluntarily recalled one lot of BIVIGAM immune globulin intravenous (human) 10% liquid after visible particles were observed during a routine annual reserve inspection. The recalled lot number is 120016 with an expiration date of Mar. 31, 2014. Inspections of other lots of product have not shown the presence of visible particles.
BIVIGAM is indicated for the treatment of patients with primary humoral immunodeficiency. Those who have purchased any of lot 120016 product are asked to discontinue distributing or using it and promptly return the vials to Biotest’s Boca Raton, Fla., facility. Healthcare professionals and patients also are encouraged to report adverse events or side effects related to the use of this product lot to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.htm.