Recall Enforment Report D-0391-2015

Recall Details

Drug Recall Enforcement Report Class I voluntary initiated by Hospira Inc., originally initiated on 10-16-2014 for the product 1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Free glass vial (Twenty-five (25) units per box/fifty (50) units per case, NDC 0409-4279-02, Hospira, Inc., Lake Forest, IL 60045 The product was recalled due to presence of particulate matter: a returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.. The product was distributed nationwide and the recall is currently terminated.

Field Name Field Value
Event ID 69567 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-0391-2015 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification 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. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description 1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Free glass vial (Twenty-five (25) units per box/fifty (50) units per case, NDC 0409-4279-02, Hospira, Inc., Lake Forest, IL 60045
Reason For Recall Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper. What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 100,100 units Product Quantity
The amount of product subject to recall.
Voluntary Mandated Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date 02-25-2015
Recall Initiation Date 10-16-2014 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Termination Date 12-29-2015 What is the Date Terminated?
The date that FDA terminated the recall.
Initial Firm Notification Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type Drugs
Recalling Firm Hospira Inc.
Code Info Lot# 40-316-DK, Exp 01APR2016 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages 0409-4713-12; 0409-4713-26; 0409-4713-02; 0409-4713-72; 0409-4713-62; 0409-4713-75; 0409-4713-65; 0409-4713-42; 0409-4713-25; 0409-4713-32; 0409-4278-16; 0409-4278-01; 0409-4279-16; 0409-4279-02; 0409-4776-10; 0409-4776-01; 0409-4282-11; 0409-4282-25; 0409-4282-01; 0409-4282-12; 0409-4282-02; 0409-4277-16; 0409-4277-01; 0409-4277-17; 0409-4277-02; 0409-4276-16; 0409-4276-01; 0409-4276-17; 0409-4276-02; 0409-4275-16; 0409-4275-01
Status Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0409-4275Lidocaine Hydrochloride Lidocaine HydrochlorideInjection, SolutionInfiltration; PerineuralHospira, Inc.Human Prescription Drug
0409-4276Lidocaine Hydrochloride Lidocaine HydrochlorideInjection, SolutionInfiltration; PerineuralHospira, Inc.Human Prescription Drug
0409-4277Lidocaine Hydrochloride Lidocaine HydrochlorideInjection, SolutionInfiltration; PerineuralHospira, Inc.Human Prescription Drug
0409-4278Lidocaine Hydrochloride Lidocaine HydrochlorideInjection, SolutionInfiltration; IntravenousHospira, Inc.Human Prescription Drug
0409-4279Lidocaine Hydrochloride Lidocaine HydrochlorideInjection, SolutionEpidural; Infiltration; Intracaudal; PerineuralHospira, Inc.Human Prescription Drug
0409-4282Lidocaine Hydrochloride Lidocaine HydrochlorideInjection, SolutionEpidural; Infiltration; Intracaudal; PerineuralHospira, Inc.Human Prescription Drug
0409-4713Lidocaine Hydrochloride Lidocaine HydrochlorideInjection, SolutionEpidural; Infiltration; Intracaudal; PerineuralHospira, Inc.Human Prescription Drug
0409-4776Lidocaine Hydrochloride Lidocaine HydrochlorideInjection, SolutionEpidural; Infiltration; Intracaudal; PerineuralHospira, Inc.Human Prescription Drug