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BIVIGAM Immune Globulin Intravenous (Human), 10 Percent Liquid, 100 mL Sterile Vial: Recall - Visible Particles Observed
AUDIENCE: Risk Manager, Infectious Disease, Health Professional
ISSUE: During a routine annual reserve inspection, visible particles were observed in lot number 120016 (Expiration Date: March 31, 2014) of BIVIGAM Immune Globulin Intravenous (Human), 10% Liquid. Biotest is voluntarily recalling this lot from the market. Inspections of other lots of product have not shown the presence of visible particles.
BACKGROUND: BIVIGAM is indicated for the treatment of patients with primary humoral immunodeficiency (PI).
RECOMMENDATION: Consignees are asked to examine stocks immediately to determine if you have any of Lot 120016 on hand. If so, discontinue distributing the lot and promptly return all vials to Biotest’s Boca Raton, Florida facility.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Recall Notice, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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