BETHESDA, MD 25 August 2010—Thirty-one lots of Octagam 5% liquid i.v. immune globulin product are being withdrawn from the market because of an increased number of reported episodes of thromboembolism, according to a notice circulated today by FDA`s MedWatch program.
The notice advises Octapharma USA customers not to administer any Octagam from the 31 lots, all of which have expiration dates in January–June 2012.
Customers with vials from those lots should quarantine them and contact the company`s customer service department at 866-766-4860.
Vijay Nair, Octapharma`s medical affairs manager and deputy local safety officer, said the company has sufficient Octagam to resupply the market.
According to the notice, nine episodes of thromboembolism have been "potentially associated" with 7 of the lots.
The other 24 lots, the notice states, are being withdrawn because of the results of a test that "may be predictive of a potential for an increased risk of thromboembolic events" from exposure to i.v. immune globulin products.
Nair said his company undertook the market withdrawal, which is not a recall, as a "proactive measure."
The company also markets Octagam 10%, which is not the subject of the current market withdrawal.
