On October 23, 2017, Octapharma USA Inc. withdrew its Octagam [Immune Globulin Intravenous (human)] 10% Liquid Preparation from the market. Octagam (immune globulin intravenous), also referred to as IVIG, is used to treat primary immunodeficiency diseases.
The market withdrawal applied to Octagam labeled with lot numbers K724B8541 & K725A8541. Although there have been no reports of serious injury at this time, Octapharma has determined, through consultation with the public health authorities at FDA, the most prudent course of action is to suspend further administration of Octagam 10 percent from these particular production lots.
See the Recall
See the FDA Safety Alert
See also Medical Law Perspectives Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication