Hydrocodone Bitartrate And Acetaminophen Tablet
FDA Recall NDC 31722-997
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 Hydrocodone Bitartrate And Acetaminophen (NDC 31722-997). A significant event, classified as Class II, was initiated on Nov 19, 2021 by Camber Pharmaceuticals, Inc.. The reported reason for this action was: "Product Mix-up"
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 II Terminated
Product Mix-up
Nov 19, 2021
Dec 15, 2021
9744 bottles
Recall Profile & Regulatory Data
Event ID
89060
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ascent Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Dec 06, 2023
Product Description
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY 11722, NDC 31722-997-01.
Batch or Lot Expiration Information
Lot# : 21070817, Exp 6/2023
Affected Packages Involved in this Recall
31722-996-01Product
31722-996-05Product
31722-997-01Product
31722-997-05Product
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.
