0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01.

Recall Number: D-395-2014

Firm: Hospira Inc.

Classification: Class II

Status: Terminated

Report Date: 20140108

Initiation Date: 20131011

Termination Date: 20141110

Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.

0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01.