Update: Blood Clot Concerns Spread Recall to All Lots of Octagam

Increase in number of reported thromboembolic events

/ Author:  / Reviewed by: Joseph V. Madia, MD

Until the cause of the previously reported thromboembolic events can be determined and corrected, Octapharma believes the most prudent course is to suspend further use of Octagam.

On August 20, 2010, in the interest of patient safety, Octapharma initiated a voluntary market withdrawal of selected lots of Octagam [Immune Globulin Intravenous (human)] 5% Liquid Preparation]. This was done due to an increased number of reported thromboembolic events (blocking of a blood vessel by a blood clot dislodged from its original site). A total of 31 lots were voluntarily withdrawn at that time.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.

Distributors and customers that receive Octagam 5% directly from Octapharma are asked to immediately quarantine these lots and contact Octapharma’s Customer Service Department for instructions regarding the return of the withdrawn product.  If you have further distributed any of these lots of Octagam to other health care providers or facilities, please contact them to quarantine these lots and instruct them to return the affected product to you.  All other customers and healthcare professionals should contact their product supplier or Octapharma Medical Affairs for further instruction.  All returns should include a copy of the Returned Goods Authorization (RGA) Form that is included with this letter, and customers should also fax a copy of that RGA form to Octapharma’s Customer Service Department at 201 604-1141.
Customer Service Department
uscustomerservice@octapharma.com

Phone: 866-766-4860
Fax: 201-604-1141

Reviewed by: 
Review Date: 
September 27, 2010