Diazepam Injection, Solution
FDA Recall NDC 0409-3213

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 4 recorded enforcement report(s) associated with Diazepam (NDC 0409-3213). A significant event, classified as Class II, was initiated on Aug 16, 2013 by Hospira, Inc.. The reported reason for this action was: "Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials."

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

D-927-2013TERMINATEDD-501-2013TERMINATEDD-313-2013TERMINATEDD-309-2013TERMINATED

August 2013 Class II Recall: Lack of assurance of sterility

Recall Number
D-927-2013
Class II Terminated
Reason for Recall
Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.
Initiated
Aug 16, 2013
Reported
Sep 04, 2013
Quantity
72,300 vials

Recall Profile & Regulatory Data

Event ID
66104
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Oct 28, 2014
Product Description
Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-3213-12
Batch or Lot Expiration Information
Lot# Lot: 23-505-EV, Exp. 11/14
Affected Packages Involved in this Recall
0409-3213-11Product
0409-3213-12Product

May 2013 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-501-2013
Class II Terminated
Reason for Recall
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Initiated
May 16, 2013
Reported
Jun 12, 2013
Quantity
95,700 vials

Recall Profile & Regulatory Data

Event ID
65315
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Nov 10, 2014
Product Description
Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12
Batch or Lot Expiration Information
Lot# 17-099-EV Exp 05/14
Affected Packages Involved in this Recall
0409-3213-11Product
0409-3213-12Product

February 2013 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-313-2013
Class II Terminated
Reason for Recall
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Initiated
Feb 26, 2013
Reported
May 15, 2013
Quantity
114,000 vials

Recall Profile & Regulatory Data

Event ID
65077
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Nov 10, 2014
Product Description
Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12
Batch or Lot Expiration Information
Lot# Lot 05-585-EV Exp. 05/13
Affected Packages Involved in this Recall
0409-3213-11Product
0409-3213-12Product

August 2012 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-309-2013
Class II Terminated
Reason for Recall
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Initiated
Aug 28, 2012
Reported
May 08, 2013
Quantity
172,350 vials

Recall Profile & Regulatory Data

Event ID
64720
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Sep 18, 2014
Product Description
Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12
Batch or Lot Expiration Information
Lot# Lot 17-100-EV and 17-399-EV
Affected Packages Involved in this Recall
0409-3213-11Product
0409-3213-12Product

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.