Notice: Baxter is voluntarily recalling one (1) lot of RECOMBINATE [Antihemophilic Factor (Recombinant)], product code 1501594, NDC Number 0944-2833-10, lot number TRA09834AB, with an expiry date of January 28, 2012.
This action is being taken as a precautionary measure after a retrospective review of manufacturing processes revealed a potential breach in aseptic processing may have occurred during the manufacture of this lot. It is important to note that this lot met all in-process and final container specifications, including sterility and pyrogenicity. There have been no reports of adverse events associated with this lot; however, in an abundance of caution, Baxter has decided to recall this particular lot of RECOMBINATE. The Food and Drug Administration
has been notified of this action.
Questions, or to obtain replacement product. Baxter’s Customer Service 800-423-2090.