Oxycodone Hydrochloride Solution
FDA Recall NDC 0054-0390
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 0054-0390). A significant event, classified as Class III, was initiated on May 19, 2016 by Hikma Pharmceuticals Usa Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specification; 9 month stability"
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
May 2016 Class III Recall: Failed Impurities/Degradation Specification; 9 month stability
Recall Number
Class III Terminated
Failed Impurities/Degradation Specification; 9 month stability
May 19, 2016
Jul 20, 2016
1,182 bottles
Recall Profile & Regulatory Data
Event ID
74253
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
West-Ward Columbus Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 02, 2017
Product Description
Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41
Batch or Lot Expiration Information
Lot# 560185A; Exp. 6/30/2017
Affected Packages Involved in this Recall
0054-0390-41Product
0054-0390-63Product
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.
