Oxybutynin Chloride Tablet
FDA Recall NDC 10702-201
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 Oxybutynin Chloride (NDC 10702-201). A significant event, classified as Class II, was initiated on Dec 11, 2018 by Kvk-tech, Inc.. The reported reason for this action was: "Labeling: Wrong bar code"
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
Labeling: Wrong bar code
Dec 11, 2018
Dec 26, 2018
156 bottles
Recall Profile & Regulatory Data
Event ID
81804
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
KVK-Tech, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed by 10 major distributors throughout the United States.
Termination Date
May 01, 2019
Product Description
Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-201-50
Batch or Lot Expiration Information
Lot# : 15079A, Exp 10/20
Affected Packages Involved in this Recall
10702-201-01Product
10702-201-50Product
10702-201-10Product
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.
