Hospira Inc.
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.
Status:Ongoing
City:Lake Forest
State:IL
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Press Release
Distribution Pattern:Nationwide.
Classification:Class I
Product Quantity:120,900 vials
Reason For Recall: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.
Recall Initiation Date:20140418
Report Date:20150211
Hospira Inc.
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.
Status:Ongoing
City:Lake Forest
State:IL
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Press Release
Distribution Pattern:Nationwide.
Classification:Class I
Product Quantity:120,900 vials
Reason For Recall: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.
Recall Initiation Date:20140418
Report Date:20150211
Hospira Inc.
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.
Status:Ongoing
City:Lake Forest
State:IL
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Press Release
Distribution Pattern:Nationwide.
Classification:Class I
Product Quantity:120,900 vials
Reason For Recall: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.
Recall Initiation Date:20140418
Report Date:20150211
Hospira Inc.
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.
Status:Ongoing
City:Lake Forest
State:IL
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Press Release
Distribution Pattern:Nationwide.
Classification:Class I
Product Quantity:120,900 vials
Reason For Recall: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.
Recall Initiation Date:20140418
Report Date:20150211
Hospira Inc.
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.
Status:Ongoing
City:Lake Forest
State:IL
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Press Release
Distribution Pattern:Nationwide.
Classification:Class I
Product Quantity:120,900 vials
Reason For Recall: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.
Recall Initiation Date:20140418
Report Date:20150211
Hospira Inc.
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.
Status:Ongoing
City:Lake Forest
State:IL
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Press Release
Distribution Pattern:Nationwide.
Classification:Class I
Product Quantity:120,900 vials
Reason For Recall: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.
Recall Initiation Date:20140418
Report Date:20150211

Lidocaine Hydrochloride

Lidocaine Hydrochloride

Lidocaine Hydrochloride Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

LIDOCAINE HYDROCHLORIDE INJECTION, FOR INFILTRATION AND NERVE BLOCK, SHOULD BE EMPLOYED ONLY BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE EMERGENCIES THAT MIGHT ARISE FROM THE BLOCK TO BE EMPLOYED AND THEN ONLY AFTER ENSURING THE IMMEDIATE AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS, CARDIOPULMONARY EQUIPMENT AND THE PERSONNEL NEEDED FOR PROPER MANAGEMENT OF TOXIC REACTIONS AND RELATED EMERGENCIES. (See also ADVERSE REACTIONS and PRECAUTIONS.) DELAY IN PROPER MANAGEMENT OF DOSE-RELATED TOXICITY, UNDERVENTILATION FROM ANY CAUSE AND/OR ALTERED SENSITIVITY MAY LEAD TO THE DEVELOPMENT OF ACIDOSIS, CARDIAC ARREST AND, POSSIBLY, DEATH.

Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions. The majority of reported cases of chondrolysis have involved the shoulder joint; cases of gleno-humeral chondrolysis have been described in pediatric and adult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods are not associated with these findings. The time of onset of symptoms, such as joint pain, stiffness and loss of motion can be variable, but may begin as early as the 2nd month after surgery. Currently, there is no effective treatment for chondrolysis; patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and some  required arthroplasty or shoulder replacement.

To avoid intravascular injection, aspiration should be performed before the local anesthetic solution is injected. The needle must be repositioned until no return of blood can be elicited by aspiration. Note, however, that the absence of blood in the syringe does not guarantee that intravascular injection has been avoided.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Lidocaine HCl injection is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.

History

There is currently no drug history available for this drug.

Other Information

Lidocaine hydrochloride has the chemical name of acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-,monohydrochloride and has the molecular weight of 270.8. Lidocaine HCl (C14H22N2O • HCl) has the following structural formula:

structural formula for Lidocaine hydrochloride

Each single-dose vial contains Lidocaine Hydrochloride Injection, USP, which is a sterile nonpyrogenic aqueous solution intended for parenteral administration as a local anesthetic agent. See INDICATIONS AND USAGE for special uses.

Each mL contains 20 mg lidocaine hydrochloride and 6 mg sodium chloride, in Water for Injection. Sodium hydroxide and/or hydrochloric acid may be used to adjust pH between 5.0 and 7.0.

Lidocaine Hydrochloride Manufacturers


  • Hospira, Inc.
    Lidocaine Hydrochloride Injection, Solution [Hospira, Inc.]
  • Mckesson Packaging Services Business Unit Of Mckesson Corporation
    Lidocaine Hydrochloride Injection, Solution [Mckesson Packaging Services Business Unit Of Mckesson Corporation]
  • Mckesson Packaging Services Business Unit Of Mckesson Corporation
    Lidocaine Hydrochloride (Lidocaine Hydrochloride Anhydrous) Injection, Solution [Mckesson Packaging Services Business Unit Of Mckesson Corporation]
  • Amphastar Pharmaceuticals, Inc.
    Lidocaine Hydrochloride Injection [Amphastar Pharmaceuticals, Inc.]
  • General Injectables & Vaccines, Inc
    Lidocaine Hydrochloride (Lidocaine Hydrochloride Anhydrous) Injection, Solution [General Injectables & Vaccines, Inc]
  • General Injectables & Vaccines, Inc
    Lidocaine Hydrochloride (Lidocaine Hydrochloride Anhydrous) Injection, Solution [General Injectables & Vaccines, Inc]
  • General Injectables & Vaccines, Inc
    Lidocaine Hydrochloride (Lidocaine Hydrochloride Anhydrous) Injection, Solution [General Injectables & Vaccines, Inc]
  • General Injectables & Vaccines, Inc
    Lidocaine Hydrochloride (Lidocaine Hydrochloride Anhydrous) Injection, Solution [General Injectables & Vaccines, Inc]
  • General Injectables & Vaccines
    Lidocaine Hydrochloride (Lidocaine) Injection, Solution [General Injectables & Vaccines]
  • Physicians Total Care, Inc.
    Lidocaine Hydrochloride (Lidocaine Hydrochloride Anhydrous) Injection, Solution [Physicians Total Care, Inc.]
  • Seton Pharmaceuticals
    Lidocaine Hydrochloride Cream [Seton Pharmaceuticals]
  • General Injectables & Vaccines, Inc
    Lidocaine Hydrochloride Injection, Solution [General Injectables & Vaccines, Inc]
  • General Injectables & Vaccines, Inc
    Lidocaine Hydrochloride Injection, Solution [General Injectables & Vaccines, Inc]
  • General Injectables & Vaccine, Inc
    Lidocaine Hydrochloride (Lidocaine) Injection, Solution [General Injectables & Vaccine, Inc]
  • General Injectables & Vaccines, Inc
    Lidocaine Hydrochloride Injection, Solution [General Injectables & Vaccines, Inc]
  • International Medication Systems, Limited
    Lidocaine Hydrochloride (Lidocaine Hydrochloride ) Solution [International Medication Systems, Limited]
  • Cardinal Health
    Lidocaine Hydrochloride (Lidocaine Hydrochloride Anhydrous) Injection, Solution [Cardinal Health]
  • Afassco Inc.
    Lidocaine Hydrochloride Liquid [Afassco Inc.]
  • Safetec Of America, Inc.
    Lidocaine Hydrochloride Liquid [Safetec Of America, Inc.]
  • International Medication Systems, Limited
    Lidocaine Hydrochloride (Lidocaine Hydrochloride ) Injection [International Medication Systems, Limited ]
  • Gensco Laboratories, Llc
    Lidocaine Hydrochloride (Lidocaine) Gel [Gensco Laboratories, Llc]
  • Auromedics Pharma Llc
    Lidocaine Hydrochloride Injection, Solution [Auromedics Pharma Llc]
  • Auromedics Pharma Llc
    Lidocaine Hydrochloride Injection, Solution [Auromedics Pharma Llc]
  • Unit Dose Services
    Lidocaine Hydrochloride (Lidocaine) Gel [Unit Dose Services]
  • Cardinal Health
    Lidocaine Hydrochloride (Lidocaine Hydrochloride Anhydrous) Injection, Solution [Cardinal Health]
  • Lake Erie Medical Dba Quality Care Products Llc
    Lidocaine Hydrochloride (Lidocaine) Gel [Lake Erie Medical Dba Quality Care Products Llc]
  • Cardinal Health
    Lidocaine Hydrochloride (Lidocaine Hydrochloride Anhydrous) Injection, Solution [Cardinal Health]
  • Cardinal Health
    Lidocaine Hydrochloride Injection, Solution [Cardinal Health]
  • Cardinal Health
    Lidocaine Hydrochloride (Lidocaine Hydrochloride Anhydrous) Injection, Solution [Cardinal Health]
  • Cardinal Health
    Lidocaine Hydrochloride (Lidocaine Hydrochloride Anhydrous) Injection, Solution [Cardinal Health]
  • Agri Laboratories, Ltd.
    Lidocaine Hydrochloride (Lidocaine) Injection [Agri Laboratories, Ltd.]
  • Remedyrepack Inc.
    Lidocaine Hydrochloride (Lidocaine Hydrochloride Anhydrous) Injection, Solution [Remedyrepack Inc. ]
  • A-s Medication Solutions Llc
    Lidocaine Hydrochloride (Lidocaine Hydrochloride Anhydrous) Injection, Solution [A-s Medication Solutions Llc]
  • Cardinal Health
    Lidocaine Hydrochloride (Lidocaine Hydrochloride Anhydrous) Injection, Solution [Cardinal Health]
  • Hospira, Inc.
    Lidocaine Hydrochloride Injection, Solution [Hospira, Inc.]
  • Remedyrepack Inc.
    Lidocaine Hydrochloride Injection, Solution [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Lidocaine Hydrochloride Injection, Solution [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Lidocaine Hydrochloride (Lidocaine Hydrochloride Anhydrous) Injection, Solution [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Lidocaine Hydrochloride (Lidocaine Hydrochloride Anhydrous) Injection, Solution [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Lidocaine Hydrochloride (Lidocaine Hydrochloride Anhydrous) Injection, Solution [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Lidocaine Hydrochloride Injection, Solution [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Lidocaine Hydrochloride (Lidocaine Hydrochloride Anhydrous) Injection, Solution [Remedyrepack Inc. ]
  • Aidarex Pharmaceuticals Llc
    Lidocaine Hydrochloride (Lidocaine) Gel [Aidarex Pharmaceuticals Llc]
  • Cardinal Health
    Lidocaine Hydrochloride Injection, Solution [Cardinal Health]
  • Mylan Institutional Llc
    Lidocaine Hydrochloride Injection [Mylan Institutional Llc ]
  • Agila Specialties Private Limited
    Lidocaine Hydrochloride Injection [Agila Specialties Private Limited]
  • Mylan Institutional Llc
    Lidocaine Hydrochloride Injection [Mylan Institutional Llc ]
  • Us Medsource, Llc
    Lidocaine Hydrochloride (Lidocaine Hydrochloride Anhydrous) Injection, Solution [Us Medsource, Llc]
  • Us Medsource, Llc
    Lidocaine Hydrochloride (Lidocaine Hydrochloride Anhydrous) Injection, Solution [Us Medsource, Llc]
  • Remedyrepack Inc.
    Lidocaine Hydrochloride (Lidocaine Hydrochloride Anhydrous) Injection, Solution [Remedyrepack Inc. ]
  • Hospira, Inc.
    Lidocaine Hydrochloride Injection, Solution [Hospira, Inc.]
  • Hospira, Inc.
    Lidocaine Hydrochloride Injection, Solution [Hospira, Inc.]
  • Proficient Rx Lp
    Lidocaine Hydrochloride (Lidocaine) Gel [Proficient Rx Lp]
  • Cardinal Health
    Lidocaine Hydrochloride (Lidocaine Hydrochloride Anhydrous) Injection, Solution [Cardinal Health]
  • Gensco Laboratories, Llc
    Lidocaine Hydrochloride (Lidocaine) Gel [Gensco Laboratories, Llc]

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