DATE Market Withdrawal INITIATED:
August 20, 2010
PRODUCT / LOT NUMBER/ Expiration date:
OCTAGAM [Immune Globulin Intravenous (human)]
5% Liquid Preparation
|Expiration Date||Vial Size (gms)|
Octapharma USA, Inc.
Hoboken, New Jersey
Octapharma USA Inc. has initiated a voluntary market withdrawal of selected lots of octagam [Immune Globulin Intravenous (human)] 5% Liquid Preparation as a result of an increased number of reported thromboembolic events, some of which were serious. This notification is to inform customers of this voluntary market withdrawal, and to advise them not to administer any product from the lots being withdrawn.
While Octapharma cannot conclusively determine that the thromboembolic events reported were associated with the use of its product, there were 9 thromboembolic events potentially associated with 7 of the lots that are being voluntarily withdrawn from the market. In collaboration with the FDA, Octapharma has developed a number of advanced testing methodologies that may be predictive of a potential for an increased risk of thromboembolic events with intravenous immune globulin products. Use of these testing methodologies has raised questions in an additional 24 lots of product that Octapharma is also voluntarily withdrawing from the market, strictly as a precautionary measure. Customers are asked to immediately quarantine the use of these lots and to contact Octapharma’s Customer Service Department 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.