Cangene Recalls HepaGam B Product Lots

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.

Patients are advised to check all product labels against the list of affected lot numbers and to quarantine any impacted inventory. For information about how to return the product, call (877) 437-2426 in the U.S. and (877) 226-4363 in Canada.