Furosemide Injection, Solution
FDA Recall NDC 0409-6102
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 Furosemide (NDC 0409-6102). A significant event, classified as Class II, was initiated on Feb 26, 2013 by Hospira, Inc.. The reported reason for this action was: "Lack of Assurance of Sterility: Loose crimp applied to the fliptop 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 II Terminated
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Feb 26, 2013
May 15, 2013
259,050 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
Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-6102-04
Batch or Lot Expiration Information
Lot# Lot 20-564-DK Exp. 02/14
Affected Packages Involved in this Recall
0409-6102-19Product
0409-6102-02Product
0409-6102-18Product
0409-6102-04Product
0409-6102-20Product
0409-6102-10Product
January 2013 Class II Recall: Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial
Recall Number
Class II Terminated
Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial
Jan 10, 2013
Mar 06, 2013
63,900 vials
Recall Profile & Regulatory Data
Event ID
64083
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 08, 2014
Product Description
Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hospira Inc., Lake Forest, IL --- NDC 0409-6102-04
Batch or Lot Expiration Information
Lot# 18-099-DK
Affected Packages Involved in this Recall
0409-6102-19Product
0409-6102-02Product
0409-6102-18Product
0409-6102-04Product
0409-6102-20Product
0409-6102-10Product
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.
