Oxycodone Hydrochloride Tablet
FDA Recall NDC 42858-005
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 42858-005). A significant event, classified as Class II, was initiated on Aug 19, 2021 by Rhodes Pharmaceuticals Llc. The reported reason for this action was: "Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle"
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
August 2021 Class II Recall: Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
Recall Number
Class II Terminated
Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
Aug 19, 2021
Sep 22, 2021
55,344/100 count bottles
Recall Profile & Regulatory Data
Event ID
88506
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Rhodes Pharmaceuticals, L.P.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide.
Termination Date
Mar 07, 2023
Product Description
Oxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottle, Rx only, Marketed by: Rhodes Pharmaceuticals L.P., Coventry RI 02816, Manufactured by: Purdue Pharma L.P., Stanford, CT 06901 NDC 42858-002-01
Batch or Lot Expiration Information
Lot# WP5K0Y, exp. date 02/28/2023
Affected Packages Involved in this Recall
42858-001-01Product
42858-001-10Product
42858-002-01Product
42858-002-10Product
42858-003-01Product
42858-004-01Product
42858-005-01Product
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.
