Ondansetron Injection, Solution
FDA Recall NDC 0409-4759
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 Ondansetron (NDC 0409-4759). A significant event, classified as Class II, was initiated on Sep 24, 2013 by Hospira, Inc.. The reported reason for this action was: "Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection 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.
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
Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Sep 24, 2013
Nov 27, 2013
681,400 vials
Recall Profile & Regulatory Data
Event ID
66422
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Oct 06, 2014
Product Description
Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest IL 60045, USA, NDC 0409-4755-03
Batch or Lot Expiration Information
Lot# 29-484-DK* and 29-510-DK* Exp 05/01/2015 (lot number may be proceeded with an 01)
Affected Packages Involved in this Recall
0409-4755-18Product
0409-4755-03Product
0409-4759-01Product
May 2013 Class II Recall: Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot
Recall Number
Class II Terminated
Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot
May 20, 2013
Aug 14, 2013
340,600 vials
Recall Profile & Regulatory Data
Event ID
65300
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 28, 2014
Product Description
Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-03, Hospira, Inc, Lake Forest, IL 60045.
Batch or Lot Expiration Information
Lot# Lot 25394DK, exp. 01/2015
Affected Packages Involved in this Recall
0409-4755-18Product
0409-4755-03Product
0409-4759-01Product
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.
