Ondansetron Injection
FDA Recall NDC 63323-374
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 63323-374). A significant event, classified as Class III, was initiated on May 22, 2019 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "Failed Impurities/Degradation Specifications."
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 III Terminated
Failed Impurities/Degradation Specifications.
May 22, 2019
Jun 19, 2019
11,981 units
Recall Profile & Regulatory Data
Event ID
82915
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Jan 28, 2021
Product Description
Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20
Batch or Lot Expiration Information
Lot# : 6018699, Exp. 12/2021
Affected Packages Involved in this Recall
63323-373-00Product
63323-373-02Product
63323-374-20Product
Class II Terminated
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Sep 27, 2012
Dec 17, 2014
184,550 Vials
Recall Profile & Regulatory Data
Event ID
63451
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide Including Puerto Rico
Termination Date
Dec 12, 2014
Product Description
ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02
Batch or Lot Expiration Information
Lot# Lot 6003930, exp. date 04/2014
Affected Packages Involved in this Recall
63323-373-00Product
63323-373-02Product
63323-374-20Product
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.
