Octagam Withdrawal Issued for All Lots
- By BSTQ Staff
Octapharma USA has initiated a voluntary withdrawal of all lots of Octagam (immune globulin intravenous [human] 5% liquid preparation)from the U.S. marketplace due to an unusually high number of thromboembolic events that have been associated with people being administered the drug. This follows an initial announcement in August of a voluntary withdrawal of selected lots of Octagam 5%, which reported at least nine events where blood clots dislodged and traveled through the body, causing injury and pain to patients.
According to Octapharma USA, while the company has not received any reports of thromboembolic events since its initial voluntary market withdrawal, “the Food and Drug Administration and Octapharma agree that until a root cause analysis of the previously reported thromboembolic events can be determined, the most prudent course of action is to suspend further administration of Octagam 5%.”
The company requests that customers quarantine all lots of Octagam 5% and then contact the Octapharma customer service department at (201) 604-1141 to return the product.
This withdrawal is for Octagam only. Octapharma’s Albumin (Human) and Wilate, Von Willebrand Factor/Coagulation Factor VIII Complex (Human), are unaffected and are readily available in all sizes for purchase.