December 2013 FDA Recall Lidocaine Hydrochloride by Hospira Inc.
D-1278-2014 - Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.

This Class I drug recall was voluntarily initiated by Hospira Inc. on December 23, 2013 for the product Lidocaine Hydrochloride. The FDA reported the reason for recall as presence of particulate matter- confimed customer complaint of particulates embedded in glass container and in contact with product solution.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1278-2014

Reason for Recall
Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.
Initiated
12-23-2013
Reported
05-07-2014
Quantity
68,350 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67140
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hospira Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2014
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# Lot 32135DD; Exp 08/15

Affected Packages Involved in this Recall

0409-2066-10 Lidocaine Hydrochloride
0409-2066-05 Lidocaine Hydrochloride