Cangene Voluntarily Recalls HepaGam B Product Lots
Date: May 31, 2012
Cangene Corp. has issued a voluntary recall of the following finished product lots associated with one bulk lot of Hepatitis B Immune Globulin ([Human] HepaGam B > 312 IU/mL): 11006960, 11006961, 11107308, 11107359, 11107360, 11007107, 11007148 and 11007151. The recall is a result of post-marketing and literature reports of serious thrombotic adverse events associated with the administration of intravenous and subcutaneous immune globulin products (IVIG, SCIG) in a wide range of patient populations. Recently, coagulation factors, including activated factor XI, have been identified in IVIG batches associated with thrombotic events. Measurable levels of procoagulant (factor XIa) activity have been detected in HepaGam B.
This Class II recall is appropriate for situations in which use of, or exposure to, a product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote. Safe levels of FXIa in immune globulin products are not known. These lots of HepaGam B have been found to contain dose levels of FXIa below, but approaching those administered in immune globulin product lots implicated in thromboembolic events.
Recall Execution Plan:
- Immediately examine your inventory.
- Immediately cease sale and/or distribution of the affected lots.
- Quarantine all current inventory.
- Reconcile all product and return to FFF Enterprises.
To arrange for return of any stock of the affected HepaGAM in your possession that you received from FFF Enterprises, please call Wow! Customer Care at 800-843-7477 for assistance with your return.