Oxycodone Hydrochloride Solution
FDA Recall NDC 60687-406
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 Oxycodone Hydrochloride (NDC 60687-406). A significant event, classified as Class II, was initiated on Feb 22, 2022 by American Health Packaging. The reported reason for this action was: "Impurity failure at 0-time of the repackaged lot."
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 2022 Class II Recall: Impurity failure at 0-time of the repackaged lot.
Recall Number
Class II Terminated
Impurity failure at 0-time of the repackaged lot.
Feb 22, 2022
Mar 16, 2022
89,880 unit-dose cups
Recall Profile & Regulatory Data
Event ID
89670
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
American Health Packaging
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jul 16, 2023
Product Description
Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Institutional Use Only, American Health Packaging, Columbus, OH 43217. UPC (01) 003 60687 406 40 4; Case NDC#: 60687-406-77, Unit Dose NDC#: 60687-406-40
Batch or Lot Expiration Information
Lot# 1004276, Exp 11/30/2022
Affected Packages Involved in this Recall
60687-406-40Product
60687-406-46Product
60687-406-77Product
60687-406-67Product
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.
