Oxycodone And Acetaminophen Tablet
FDA Recall NDC 13107-044
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 And Acetaminophen (NDC 13107-044). A significant event, classified as Class II, was initiated on Mar 18, 2020 by Aurolife Pharma, Llc. The reported reason for this action was: "CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed"
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
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Mar 18, 2020
Apr 22, 2020
14707 units
Recall Profile & Regulatory Data
Event ID
85183
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Mar 25, 2024
Product Description
Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-046-01
Batch or Lot Expiration Information
Lot# : 046180056A, Exp. Date 05/2020
Affected Packages Involved in this Recall
13107-043-30Product
13107-043-01Product
13107-043-05Product
13107-043-99Product
13107-044-30Product
13107-044-01Product
13107-044-05Product
13107-044-99Product
13107-045-30Product
13107-045-01Product
13107-045-05Product
13107-045-99Product
13107-046-30Product
13107-046-01Product
13107-046-05Product
13107-046-99Product
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.
