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Octagam (Immune Globulin Intravenous (human)) 5% Liquid Preparation: Market Withdrawal - Risk of Thromboembolic Events
[UPDATED 09/24/2010] Octapharma USA and FDA notified healthcare professionals that, effective immediately, Octapharma is initiating a voluntary market withdrawal of ALL lots of Octagam currently in the US market. 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.
Read the MedWatch safety alert, including a link to the updated Voluntary Market Withdrawal notice, at:
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