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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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URGENT - Voluntary Market Withdrawal of Octagam [Immune Globulin Intravenous (human)] 5% Liquid Preparation

DATE Market Withdrawal INITIATED:

August 20, 2010

PRODUCT / LOT NUMBER/ Expiration date:

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


Lot Number
Expiration DateVial Size (gms)
A002B84311/11/20125
A004A84311/27/201210
A004B84311/28/201210
A008B84312/25/201210
A008C84312/28/20125
A009A84313/3/201210
A009C84313/4/201210
A010A84313/10/201210
A010C84313/11/201210
A011B84313/17/201210
A011C84313/18/201210
A012B84313/24/201210
A012C84313/25/201210
A012D84313/25/201210
A012E84313/26/201210
A013A84313/31/20125
A013B84313/31/20125
A013C84314/1/201210
A014A84314/7/20125
A014B84314/7/201210
A014C84314/8/201210
A014D84314/8/201210
A015A84314/14/201210
A015B84314/15/201210
A015C84314/15/201210
A016B84314/22/201210
A016C84314/23/201210
A016D84314/22/201210
C011C84313/18/201210
C013C84314/1/201210
C025A84316/23/201210

MANUFACTURER:

Octapharma USA, Inc.
Hoboken, New Jersey

REASON:
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customers of this voluntary market withdrawal, and to advise them not to administer any product from the lots being withdrawn.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of its product, there were 9 thromboembolic events potentially associated with 7 of the lots that are being voluntarily withdrawn from the market.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.

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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.