Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205

Recall Number: D-1218-2014

Firm: Zions RX Formulations Services LLC dba RX Formuations Serv.

Classification: Class II

Status: Terminated

Report Date: 20140416

Initiation Date: 20131212

Termination Date: 20140501

Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.

Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205