Pharmacy Services
Octagam (Immune Globulin Intravenous 5% Liquid) Market Withdrawal - Update
September 24, 2010
Octapharma issued a voluntary market withdrawal of all lots of Octagam Liquid intravenous immune globulin 5%. In August, 2010, 7 lots were withdrawn from the market due to 9 reports of thromboembolic events associated with the use of 7 different lots. An additional 24 lots were withdrawn in August, 2010 because of the potential to cause thromboembolic events based on testing from the manufacturer and FDA. Adverse events have not been reported since the original 31 lots were pulled. However, Octagam will be withdrawn from the market until the cause of the thromboembolic events can be identified and resolved.
Do not use Octagam and quarantine the product. Contact Octapharma’s Customer Service Department at 1-866-766-4860 for information on how to return affected product.
Additional information can be found at the following links:
- FDA Recall Report:
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm227133.htm - MedWatch Report:
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm223897.htm - Octapharma Press Release:
Updated
September 24, 2010; August 25, 2010; University of Utah, Drug Information Service. Copyright 2010, Drug Information Service, University of Utah, Salt Lake City, UT.
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