URGENT: VOLUNTARY MARKET WITHDRAWAL
 
Initiated by :  Octapharma USA Inc.
Event Id :  162
Event Date :  04-25-2016
Therapy
Octagam®
NDC Number Lot Number Size Packaging Expiration Date
68982 – 840 – 04 K551A8441 200 mL Vials 12-17-2017
Reason OCTAGAM 5% [IMMUNE GLOBULIN INTRAVENOUS (human)] LIQUID PREP


This withdrawal of one lot of Octagam 5% is being conducted as a precautionary measure due to an increased number of reports of hypersensitivity reactions such as rashes or urticaria and/or wheezing.
Action 1) Please check all Octogam 5% labels for presence of affected lot (K551A441).
2) Do not infuse this product. Return affected withdrawn lots to the point of purchase to receive replacement product.
3) Contact your physician if you have medical questions.
4) For clinical questions about Octagam 5%, contact Dipen Patel, Head, US Drug Safety Unit at 201 604 1137
Other Information If you need assistance, please call Sedgwick, Inc. at 1-888-UPDATE-U.