Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve Block, Caudal, and Epidural Anesthesia, Not for Spinal Anesthesia, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1162-02

Recall Number: D-1588-2014

Firm: Hospira Inc.

Classification: Class II

Status: Terminated

Report Date: 20140924

Initiation Date: 20140904

Termination Date: 20150723

Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial.

Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve Block, Caudal, and Epidural Anesthesia, Not for Spinal Anesthesia, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1162-02