Biotest Pharmaceuticals Corporation (BPC) has initiated a voluntary recall of several lots of BIVIGAM due to the potential for a very small percentage of the 100 mL vials having a vial integrity defect. In the rare event that a vial is affected, the defect could potentially result in leakage.
After an extensive investigation by BPC, the contract filler and the vial manufacturer, it has been concluded that this event has only been observed in glass vials from one manufacturing run of glass vials. Vials from this manufacturing run were used to fill the affected lots of BIVIGAM.
CLICK HERE to view the biologic recall, which includes the affected lots of BIVIGAM.