Octapharma USA Inc., is initiating a voluntary market withdrawal of two lots of the intravenous immune Globulin (IVIG) Octagan after consulting with public health authorities at the Food and Drug Administration (FDA). To date, the company has not received any reports of adverse events related to these recalled products.
Octagan is a human blood product consisting of antibodies that are used to treat immunodeficiency disorders, B-cell chronic lymphocytic leukemia, and inflammatory demyelinating disorders. The recall affects octagam 10% Globulin Intravenous (human) [10% Liquid Preparation] that is labeled with the lot numbers K724B8541 and K725A8541, and expiration dates June 14, 2019, and June 23, 2019, respectively.
Octapharma is asking its distributors that have received affected lots of octagam 10% from Octapharma to immediately quarantine them and contact Octapharma for return instructions.
All intravenous immune globulin products including octagam have been associated with hypersensitivity reactions including hives and itching, according to published literature and post-marketing surveillance. The potential of these adverse events is listed on the products’ package inserts.
Any adverse events related to this recall should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
FDA Recall Notice