Safety Alerts & Recalls

What does this mean?

There are several immune globulin intravenous products available on the market and most patients will not be affected by this recall. If you have been receiving Octagam infusions and have concerns, please follow up with your doctor or other healthcare provider.

Manufacturer Withdraws All Lots of Octagam

Octapharma USA Inc. is issuing a voluntary market withdrawal of ALL lots of Octagam [Immune Globulin Intravenous (human)] 5% Liquid Preparation] currently in the US market. In August 2010, in the interest of patient safety, Octapharma USA Inc. initiated a voluntary market withdrawal of selected lots of Octagam at the wholesale and hospital/clinic level because of an increased number of reported blood clotting events, some of which were serious. A total of 31 lots were voluntarily withdrawn at that time.

Octapharma has not received any reports of thromboembolic events since the August 20, 2010. However, Octapharma, in consultation with the FDA, has determined that the best course of action is to stop further administration of Octagam until a reason for the previously reported clotting events can be determined and the problem corrected.

For more information, please visit: more information here

Source: FDA
Publication Date: 2010-09-28
Last Updated: 2010-09-28

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