Oseltamivir Phosphate For Suspension
FDA Recall NDC 69238-1273
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Oseltamivir Phosphate (NDC 69238-1273). A significant event, classified as Class II, was initiated on Feb 13, 2024 by Amneal Pharmaceuticals Ny Llc. The reported reason for this action was: "Failed Impurities/Degradation Specifications: Out-of-specification test results."
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
February 2024 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications: Out-of-specification test results.
Feb 13, 2024
Feb 28, 2024
46,037 Bottles
Recall Profile & Regulatory Data
Event ID
93959
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Amneal Pharmaceuticals of New York, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Feb 14, 2025
Product Description
Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC# 69238-1273-6
Batch or Lot Expiration Information
Lot# BF22722A, Exp. 08/31/2024; BJ15122A, Exp. 09/30/2024
Affected Packages Involved in this Recall
69238-1273-6Product
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.
