Oxycodone Hydrochloride Tablet
FDA Recall NDC 31722-484
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 31722-484). A significant event, classified as Class III, was initiated on Jan 22, 2018 by Camber Pharmaceuticals Inc. The reported reason for this action was: "Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol"
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
January 2018 Class III Recall: Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol
Recall Number
Class III Terminated
Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol
Jan 22, 2018
Feb 07, 2018
45,875 bottles
Recall Profile & Regulatory Data
Event ID
78990
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Ascent Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Apr 23, 2018
Product Description
Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manufactured for Camber Pharmaceuticals, Inc., Piscataway, NJ, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY --- NDC 31722-917-01
Batch or Lot Expiration Information
Lot# Lot Numbers: 17080591 and 17080619, exp 07/19; 17110907 and 17110908, exp 10/19; and 17120986, exp 11/19
Affected Packages Involved in this Recall
31722-484-01Product
31722-484-05Product
31722-485-01Product
31722-485-05Product
31722-917-01Product
31722-917-05Product
31722-486-01Product
31722-486-05Product
31722-918-01Product
31722-918-05Product
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.
