Lidocaine Hydrochloride Injection, Solution
FDA Recall NDC 0409-9137
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 0409-9137). A significant event, classified as Class I, was initiated on Oct 02, 2023 by Hospira, Inc.. The reported reason for this action was: "Presence of Particulate Matter: identified as glass."
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: identified as glass.
Oct 02, 2023
Nov 15, 2023
21,390 vials
Recall Profile & Regulatory Data
Event ID
93124
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.
Termination Date
Feb 14, 2025
Product Description
1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4904-11
Batch or Lot Expiration Information
Lot# : 42290DK, Exp. 6/1/2024
Affected Packages Involved in this Recall
0409-4903-11Product
0409-4903-34Product
0409-4904-11Product
0409-4904-34Product
0409-1323-15Product
0409-1323-05Product
0409-9137-11Product
0409-9137-05Product
Class I Terminated
Presence of Particulate Matter: identified as glass.
Oct 02, 2023
Nov 15, 2023
3,200 vials
Recall Profile & Regulatory Data
Event ID
93124
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.
Termination Date
Feb 14, 2025
Product Description
2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4903-11
Batch or Lot Expiration Information
Lot# : GH6567, Exp. 7/1/2024
Affected Packages Involved in this Recall
0409-4903-11Product
0409-4903-34Product
0409-4904-11Product
0409-4904-34Product
0409-1323-15Product
0409-1323-05Product
0409-9137-11Product
0409-9137-05Product
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.
