Vaccines, Blood & Biologics

Recall of BIVIGAM Immune Globulin Intravenous (Human)

DATE RECALL INITIATED:

February 20, 2014

PRODUCT / LOT NUMBER

BIVIGAM Immune Globulin Intravenous (Human), 10% Liquid, 100mL vial

NDC Number 59730-6503-1

Lot Number

Expiration Date

130009

5/31/15

130011

5/31/15

130013

5/31/15

130019

5/31/15

130021

5/31/15

130023

5/31/15

130029

6/30/15

130033

6/30/15

130035

6/30/15

130037

6/30/15

130039

6/30/15

130041

6/30/15

130043

7/31/15

130137

5/31/15

MANUFACTURER:

Biotest Pharmaceuticals Corporation (BPC)

Boca Raton, FL

REASON:

Biotest Pharmaceuticals Corporation (BPC) has initiated a voluntary recall of the listed BIVIGAM (Immune Globulin Intravenous (Human), 10% Liquid), 100 mL lot numbers because there is the potential that a very small percentage of the vials may exhibit a vial integrity defect. In the rare event that a vial is affected, the defect could potentially result in leakage. BPC is taking this action as a precautionary measure in the interest of patient safety because the defect may not be readily apparent when the end user prepares the product for administration. Consignees are asked to quarantine all vials from the above listed lots and communicate with BPC to arrange for product return.  


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: 03/19/2015
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