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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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
Lot130023
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.