BIVIGAM Immune Globulin Intravenous (Human)
April 9, 2013
Biotest has voluntarily recalled Lot 120016 of BIVIGAM Immune Globulin Intravenous (Human) 10% Liquid due to visible particles observed during an annual inspection. The affected lot has an expiration date of March 31, 2014. Other lots did not contain visible particles, and are not being recalled.
Examine inventory immediately for Lot 120016. Discontinue use and distribution of the affected lot and return vials to Biotest’s Boca Raton, Florida facility.
Adverse events or side effects may be reported to FDA’s MedWatch Safety Information and Adverse Event Reporting Program online at http://www.fda.gov/MedWatch/report.htm.
- MedWatch Alert:
- Recall Notice:
April 9, 2013; University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.