Lidocaine Hydrochloride Injection, Solution
FDA Recall NDC 0409-2066
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Lidocaine Hydrochloride (NDC 0409-2066). A significant event, classified as Class I, was initiated on Jul 29, 2014 by Hospira, Inc.. The reported reason for this action was: "Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial."
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
Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial.
Jul 29, 2014
Oct 22, 2014
109,110 Vials
Recall Profile & Regulatory Data
Event ID
68901
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 17, 2017
Product Description
Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Single-Dose Vial, Rx only, For Infiltration and Nerve Block including Epidural and Caudal, Manufactured by: Hospira, Inc., Lake Forest, IL, 60045, NDC 0409-2066-05
Batch or Lot Expiration Information
Lot# Lot Number: 25-550-DD, Exp: 1JAN2015
Affected Packages Involved in this Recall
0409-2066-10Product
0409-2066-05Product
December 2013 Class I Recall: Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.
Recall Number
Class I Terminated
Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.
Dec 23, 2013
May 07, 2014
68,350 vials
Recall Profile & Regulatory Data
Event ID
67140
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 07, 2014
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.
Batch or Lot Expiration Information
Lot# Lot 32135DD; Exp 08/15
Affected Packages Involved in this Recall
0409-2066-10Product
0409-2066-05Product
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.
