Supply Updates

December 2020: Notification of Recall/Out of Stock for Zerbaxa.

Product Recall Notification - ZERBAXA (ceftolozane/tazobactam) 

This is to inform you of a voluntary global recall of all batches of ZERBAXA (ceftolozane/tazobactam). This recall is going to hospital level and in Ireland this action has been agreed with the Health Products Regulatory Authority (HPRA).

Due to a recent manufacturing issue identified during routine internal post-manufacturing release testing of ZERBAXA (ceftolozane/tazobactam), manufacturing of the product was stopped.  The testing produced sterility results that were out of specification. 

Our internal investigation is ongoing and a root cause for the test results that were out of specification has not been determined.  Therefore, the scope of the investigation includes all ZERBAXA batches within expiry. 

ZERBAXA Notification

 

IE-NON-00125|Date of preparation : September 2020