November 2013 - Precautionary Product Recall Evogam

Precautionary Product Recall - Evogam

Evogam 20mL batch 3810200087 and Evogam 5mL batch 3810050088

CSL Behring (Australia) Pty Ltd ("CSL Behring") is recalling the above batches of Evogam, due to the potential that a low number of defective stoppers (rubber enclosure) may have been used in the manufacture of these batches.

The supplier of stoppers used in the manufacturing process, has advised CSL Behring of the potential that a portion of the stoppers used in these batches may be defective. As this may affect the container integrity, CSL Behring is recalling these batches to confirm container integrity.

NZBS received the two batches of recalled product in October 2013. The six patients who have been issued with these batches of Evogam have been contacted by NZBS about the recall. Evogam from unaffected batches will be supplied to these patients to ensure continuity of treatment.

If you have not been contacted regarding the recall it means that you do not have one of the affected batches so there is no need for concern.

If you do have any clinical questions about this product recall please contact your immunologist or immunology nurse specialist.