URGENT: Voluntary Market Withdrawal
 
Initiated by :  Octapharma USA Inc.
Event Id :  143
Event Date :  08-20-2010
Therapy
OctagamŽ
NDC Number Lot Number Size Packaging Expiration Date
67467 0843 03 A002B8431 5 GM Vial 01-01-2012
67467 0843 03 A008C8431 5 GM Vial 02-28-2012
67467 0843 04 A009A8431 10 GM Vial 03-03-2012
67467 0843 04 A009C8431 10 GM Vial 03-04-2012
67467 0843 04 A010A8431 10 GM Vial 03-10-2012
67467 0843 04 A010C8431 10 GM Vial 03-11-2012
67467 0843 04 A011B8431 10 GM Vial 03-17-2012
67467 0843 04 A011C8431 10 GM Vial 03-18-2012
67467 0843 04 A012B8431 10 GM Vial 03-24-2012
67467 0843 04 A012C8431 10 GM Vial 03-25-2012
67467 0843 04 A012D8431 10 GM Vial 03-25-2012
67467 0843 04 A012E8431 10 GM Vial 03-26-2012
67467 0843 03 A013A8431 5 GM Vial 03-31-2012
67467 0843 03 A013B8431 5 GM Vial 03-31-2012
67467 0843 04 A013C8431 10 GM Vial 04-01-2012
67467 0843 03 A014A8431 5 GM Vial 04-07-2012
67467 0843 04 A014B8431 10 GM Vial 04-07-2012
67467 0843 04 A014C8431 10 GM Vial 04-08-2012
67467 0843 04 A014D8431 10 GM Vial 04-08-2012
67467 0843 04 A015A8431 10 GM Vial 04-14-2012
67467 0843 04 A015B8431 10 GM Vial 04-15-2012
67467 0843 04 A015C8431 10 GM Vial 04-15-2012
67467 0843 04 A016B8431 10 GM Vial 04-22-2012
67467 0843 04 A016C8431 10 GM Vial 04-23-2012
67467 0843 04 A016D8431 10 GM Vial 04-22-2012
68209 0843 04 C011C8431 10 GM Vial 03-18-2012
68209 0843 04 C013C8431 10 GM Vial 04-01-2012
68209 0843 04 C025A8431 10 GM Vial 06-23-2012
67467 0843 04 A004A8431 10 GM Vial 01-27-2012
67467 0843 04 A004B8431 10 GM Vial 01-28-2012
67467 0843 04 A008B8431 10 GM Vial 02-25-2012
Reason This voluntary withdrawal is being conducted as a precautionary measure. In the interest of patient safety, Octapharma USA Inc. has initiated a voluntary market withdrawal of selected lots of octagamŽ [immune globulin intravenous (human)] 5% Liquid Preparation] as a result of an increased number of reported thromboembolic events, some of which were serious.
Action 1) Please check all product labels against the list of affected lot numbers.
2) Do not take this product. Return any product from the withdrawn lots to the point of purchase or to your healthcare provider.
3) Contact your physician if you have medical questions.
Other Information If you need assistance, please call Octapharma USA Medical Affairs Department at 360 990 4318.