Oxycodone Hydrochloride Solution
FDA Recall NDC 64950-354
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 64950-354). A significant event, classified as Class III, was initiated on Dec 23, 2020 by Genus Lifesciences Inc.. The reported reason for this action was: "Presence of Foreign Substance: Particulate matter was found in multiple lots of product."
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
Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Dec 23, 2020
Jan 20, 2021
1,171,550 cups
Recall Profile & Regulatory Data
Event ID
87044
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Genus Lifesciences Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Nov 05, 2021
Product Description
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950-354-05 Case NDC: 64950-354-450(40 unit dose cups) Case NDC 64950-354-55 (50 unit dose cups)
Batch or Lot Expiration Information
Lot# 35400119A, 35400219A, 35400319A, 35400419A , 35400519A , 35400619A, EXP 12/31/20; 35400719A, 35400819A, EXP 1/31/21; 35400919A, 35401019A, 35401119A, EXP 2/28/21; 35401219A, 35401319A, EXP 4/30/21; 35401419A, 35401519A, 35401619A, EXP 5/31/21; 35401719A, 35401819A, EXP 7/31/21; 35401919A, 35402019A, EXP 8/31/21; 35402119A, 35402219A, 35402319A, 35402419A, EXP 9/30/21; 35402519A, EXP 10/31/21; 35402619A, 35402719A, EXP 11/30/21; 35400120A, 35400220A, 35400320A, 35400420B, EXP 12/31/21; 35400520A, EXP 1/31/22, 35400620A, EXP 1/31/22.
Affected Packages Involved in this Recall
64950-353-03Product
64950-353-01Product
64950-353-91Product
64950-353-51Product
64950-353-02Product
64950-353-92Product
64950-353-52Product
64950-354-10Product
64950-354-50Product
64950-354-05Product
64950-354-55Product
64950-354-45Product
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.
