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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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URGENT: Voluntary Market Withdrawal - September 23, 2010 Octagam [Immune Globulin Intravenous (Human)] 5% Liquid Preparation

DATE MARKET WITHDRAWAL INITIATED:

September 23, 2010

PRODUCT:

Octagam [Immune Globulin Intravenous (human)] 5% Liquid Preparation

MANUFACTURER:

Octapharma USA, Inc.
Hoboken, NJ

REASON:

On August 20, 2010, in the interest of patient safety, Octapharma USA Inc. initiated a voluntary market withdrawal of selected lots of octagam® [Immune Globulin Intravenous (human)] 5% Liquid Preparation]. This was performed as a result of an increased number of reported thromboembolic events, some of which were serious. A total of 31 lots were voluntarily withdrawn at that time.

Effective immediately, Octapharma USA Inc. is initiating a voluntary market withdrawal of ALL lots of octagam® [Immune Globulin Intravenous (human)] 5% Liquid Preparation] currently in the US market. While Octapharma has not received any reports of thromboembolic events since the August 20, 2010, voluntary market withdrawal was performed, Octapharma has determined, through consultation with the public health authorities at FDA, that until a root cause of the previously reported thromboembolic events can be determined and the problem corrected, the most prudent course of action is to suspend further administration of octagam®.

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.