URGENT: BIOLOGIC RECALL INFORMATION
Initiated by :  Biotest Pharmaceuticals Corporation Event Id :  157 Event Date :  02-20-2014

Therapy	Bivigam NDC Number Lot Number Size Packaging Expiration Date 59730-6503-1 130009 10 g Vial 05-31-2015 59730-6503-1 130011 10 g Vial 05-31-2015 59730-6503-1 130013 10 g Vial 05-31-2015 59730-6503-1 130019 10 g Vial 05-31-2015 59730-6503-1 130021 10 g Vial 05-31-2015 59730-6503-1 130023 10 g Vial 05-31-2015 59730-6503-1 130029 10 g Vial 06-30-2015 59730-6503-1 130033 10 g Vial 06-30-2015 59730-6503-1 130035 10 g Vial 06-30-2015 59730-6503-1 130037 10 g Vial 06-30-2015 59730-6503-1 130039 10 g Vial 06-30-2015 59730-6503-1 130041 10 g Vial 06-30-2015 59730-6503-1 130043 10 g Vial 07-31-2015 59730-6503-1 130137 10 g Vial 05-31-2015
Reason	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. 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. To ensure patient safety, your team should immediately quarantine all vials from the affected lots, even though only a small percentage of vials could be affected. This voluntary recall is conducted due to defective primary packaging material and not due to the drug substance produced by BPC at our Boca Raton, Florida manufacturing facility. Only the lot numbers listed are affected by this action. BIVIGAM, 50 mL (5g) is not involved in this action. The Food and Drug Administration (FDA) has been notified.
Action	Please examine your stocks immediately to determine if you have any vials of the aforementioned lots on hand. If so, discontinue use of these lots and promptly return all vials to the point of purchase.
Other Information	For Medical Information questions, please call Medical Affairs at 1-800-458-4244 prompt 2.