Vaccines, Blood & Biologics

Urgent – Drug Recall - BIVIGAM Immune Globulin Intravenous (Human), 10% Liquid, 100 mL sterile vial

DATE RECALL INITIATED: April 2, 2013

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Lot # 120016
Expiration Date: March 31, 2014

MANUFACTURER:

Biotest Pharmaceuticals Corporation
Boca Raton, FL

REASON:

During a routine annual reserve inspection, visible particles were observed in the above lot number of BIVIGAM Immune Globulin Intravenous (Human), 10% Liquid. In the interest of patient safety, Biotest is voluntarily recalling this lot from the market. Inspections of other lots of product have not shown the presence of visible particles; therefore, no other lots of product are affected by this recall. Consignees are asked to examine your 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 using the enclosed return label.


The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

Page Last Updated: 08/20/2014
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