Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose vials, 10 vials per...

FDA Recall #D-1278-2014 — Class I — December 23, 2013

Recall #D-1278-2014 Date: December 23, 2013 Classification: Class I Status: Terminated

Product Description

Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose vials, 10 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL. 60045, NDC 0409-2066-05.

Reason for Recall

Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.

Recalling Firm

Hospira Inc. — Lake Forest, IL

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

68,350 vials

Distribution

Nationwide

Code Information

Lot 32135DD; Exp 08/15

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated