Lidocaine Hydrochloride Injection, Solution
FDA Recall NDC 0409-4713
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 6 recorded enforcement report(s) associated with Lidocaine Hydrochloride (NDC 0409-4713). A significant event, classified as Class I, was initiated on May 03, 2021 by Hospira, Inc.. The reported reason for this action was: "Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
May 03, 2021
Jun 09, 2021
139,050 vials
Recall Profile & Regulatory Data
Event ID
87837
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
PFIZER, INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA, Puerto Rico, and Guam
Termination Date
Apr 04, 2023
Product Description
1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose vial (NDC 0409-4279-16), packaged in 25 vials per tray (NDC 0409-4279-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA.
Batch or Lot Expiration Information
Lot# Lot EG8933, Exp. 08/01/2022
Affected Packages Involved in this Recall
0409-4713-12Product
0409-4713-26Product
0409-4713-02Product
0409-4713-72Product
0409-4713-62Product
0409-4713-75Product
0409-4713-65Product
0409-4713-42Product
0409-4713-25Product
0409-4713-32Product
0409-4278-16Product
0409-4278-01Product
0409-4279-16Product
0409-4279-02Product
0409-4776-10Product
0409-4776-01Product
0409-4282-11Product
0409-4282-25Product
0409-4282-01Product
0409-4282-12Product
0409-4282-02Product
0409-4277-16Product
0409-4277-01Product
0409-4277-17Product
0409-4277-02Product
0409-4276-16Product
0409-4276-01Product
0409-4276-17Product
0409-4276-02Product
0409-4275-16Product
0409-4275-01Product
Class II Ongoing
Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.
Aug 25, 2015
Sep 30, 2015
100,200 Vials
Recall Profile & Regulatory Data
Event ID
72072
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Hospira, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservative Free, Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-4279-02
Batch or Lot Expiration Information
Lot# : 44-359-DK, Exp 08/01/2016
Affected Packages Involved in this Recall
0409-4713-12Product
0409-4713-26Product
0409-4713-02Product
0409-4713-72Product
0409-4713-62Product
0409-4713-75Product
0409-4713-65Product
0409-4713-42Product
0409-4713-25Product
0409-4713-32Product
0409-4278-16Product
0409-4278-01Product
0409-4279-16Product
0409-4279-02Product
0409-4776-10Product
0409-4776-01Product
0409-4282-11Product
0409-4282-25Product
0409-4282-01Product
0409-4282-12Product
0409-4282-02Product
0409-4277-16Product
0409-4277-01Product
0409-4277-17Product
0409-4277-02Product
0409-4276-16Product
0409-4276-01Product
0409-4276-17Product
0409-4276-02Product
0409-4275-16Product
0409-4275-01Product
Class I Terminated
Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.
Oct 16, 2014
Feb 25, 2015
100,100 units
Recall Profile & Regulatory Data
Event ID
69567
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Dec 29, 2015
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
Batch or Lot Expiration Information
Lot# 40-316-DK, Exp 01APR2016
Affected Packages Involved in this Recall
0409-4713-12Product
0409-4713-26Product
0409-4713-02Product
0409-4713-72Product
0409-4713-62Product
0409-4713-75Product
0409-4713-65Product
0409-4713-42Product
0409-4713-25Product
0409-4713-32Product
0409-4278-16Product
0409-4278-01Product
0409-4279-16Product
0409-4279-02Product
0409-4776-10Product
0409-4776-01Product
0409-4282-11Product
0409-4282-25Product
0409-4282-01Product
0409-4282-12Product
0409-4282-02Product
0409-4277-16Product
0409-4277-01Product
0409-4277-17Product
0409-4277-02Product
0409-4276-16Product
0409-4276-01Product
0409-4276-17Product
0409-4276-02Product
0409-4275-16Product
0409-4275-01Product
Class I Terminated
Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.
Apr 18, 2014
Feb 11, 2015
120,900 vials
Recall Profile & Regulatory Data
Event ID
69327
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Nov 07, 2017
Product Description
1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4279-02.
Batch or Lot Expiration Information
Lot# Lot number: 31-427-DK, Exp 01JUL2015.
Affected Packages Involved in this Recall
0409-4713-12Product
0409-4713-26Product
0409-4713-02Product
0409-4713-72Product
0409-4713-62Product
0409-4713-75Product
0409-4713-65Product
0409-4713-42Product
0409-4713-25Product
0409-4713-32Product
0409-4278-16Product
0409-4278-01Product
0409-4279-16Product
0409-4279-02Product
0409-4776-10Product
0409-4776-01Product
0409-4282-11Product
0409-4282-25Product
0409-4282-01Product
0409-4282-12Product
0409-4282-02Product
0409-4277-16Product
0409-4277-01Product
0409-4277-17Product
0409-4277-02Product
0409-4276-16Product
0409-4276-01Product
0409-4276-17Product
0409-4276-02Product
0409-4275-16Product
0409-4275-01Product
Class I Terminated
Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride Injection, USP.
Sep 16, 2013
Apr 23, 2014
374,500 vials
Recall Profile & Regulatory Data
Event ID
66441
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Hospira, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Nov 04, 2014
Product Description
1% Lidocaine HCl Injection, USP, 10 mg/mL, NDC 0409-4276-01, Hospira, Inc., Lake Forest, IL 60045.
Batch or Lot Expiration Information
Lot# 25090DK; Exp 01/15
Affected Packages Involved in this Recall
0409-4713-12Product
0409-4713-26Product
0409-4713-02Product
0409-4713-72Product
0409-4713-62Product
0409-4713-75Product
0409-4713-65Product
0409-4713-42Product
0409-4713-25Product
0409-4713-32Product
0409-4278-16Product
0409-4278-01Product
0409-4279-16Product
0409-4279-02Product
0409-4776-10Product
0409-4776-01Product
0409-4282-11Product
0409-4282-25Product
0409-4282-01Product
0409-4282-12Product
0409-4282-02Product
0409-4277-16Product
0409-4277-01Product
0409-4277-17Product
0409-4277-02Product
0409-4276-16Product
0409-4276-01Product
0409-4276-17Product
0409-4276-02Product
0409-4275-16Product
0409-4275-01Product
Class II Terminated
Presence of Particulate Matter: Report of a vial containing visible particulate matter embedded in the glass wall which has the potential to dislodge resulting in the presence of particulate matter in the product.
Oct 04, 2012
Dec 26, 2012
120,350 vials
Recall Profile & Regulatory Data
Event ID
63913
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
May 08, 2014
Product Description
Lidocaine HCl Injection, USP, 1% (10 mg/mL), 30 mL Single-dose Teartop Vial, packaged in 25-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-4279-02.
Batch or Lot Expiration Information
Lot# : 14-277-DK*, Exp 02/01/14; * may be followed by 01
Affected Packages Involved in this Recall
0409-4713-12Product
0409-4713-26Product
0409-4713-02Product
0409-4713-72Product
0409-4713-62Product
0409-4713-75Product
0409-4713-65Product
0409-4713-42Product
0409-4713-25Product
0409-4713-32Product
0409-4278-16Product
0409-4278-01Product
0409-4279-16Product
0409-4279-02Product
0409-4776-10Product
0409-4776-01Product
0409-4282-11Product
0409-4282-25Product
0409-4282-01Product
0409-4282-12Product
0409-4282-02Product
0409-4277-16Product
0409-4277-01Product
0409-4277-17Product
0409-4277-02Product
0409-4276-16Product
0409-4276-01Product
0409-4276-17Product
0409-4276-02Product
0409-4275-16Product
0409-4275-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
