Biotest Pharmaceuticals is recalling a lot of Bivigam (immune globulin intravenous [human], 10%) after visible particles were observed during a routine annual reserve inspection. Bivigam is indicated for the treatment of patients with primary humoral immunodeficiency (PI).
The affected product has lot # 120016 with an expiration date March 31, 2014. Inspections of other lots have not shown the presence of visible particles. Bivigam is available in a 10% liquid in 50mL and 100mL tamper-evident vials.
Consignees are recommended to discontinue distributing the affected lot and promptly return all vials to Biotest’s Boca Raton, FL facility.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm346771.htm.