Oxycodone Hydrochloride Tablet
FDA Recall NDC 43386-430
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 43386-430). A significant event, classified as Class III, was initiated on Dec 29, 2021 by Lupin Pharmaceuticals,inc.. The reported reason for this action was: "Out-of-specification impurity test result observed at 18-month long term stability time point."
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
December 2021 Class III Recall: Out-of-specification impurity test result observed at 18-month long term stability time point.
Recall Number
Class III Terminated
Out-of-specification impurity test result observed at 18-month long term stability time point.
Dec 29, 2021
Jan 12, 2022
23,965 100 count bottles
Recall Profile & Regulatory Data
Event ID
89324
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product Distributed in NY and OH.
Termination Date
Aug 23, 2022
Product Description
Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-432-01
Batch or Lot Expiration Information
Lot# S000268, Exp. date January 2022
Affected Packages Involved in this Recall
43386-432-01Product
43386-432-03Product
43386-432-05Product
43386-433-01Product
43386-433-03Product
43386-433-05Product
43386-430-01Product
43386-430-05Product
43386-430-03Product
43386-434-01Product
43386-434-05Product
43386-434-03Product
43386-431-01Product
43386-431-03Product
43386-431-05Product
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.
