Oxybutynin Chloride Tablet, Extended Release
FDA Recall NDC 42291-635
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 42291-635). A significant event, classified as Class III, was initiated on Mar 01, 2019 by Avkare. The reported reason for this action was: "Failed Dissolution Specifications"
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 III Terminated
Failed Dissolution Specifications
Mar 01, 2019
Mar 20, 2019
a) 2947 and b) 3379
Recall Profile & Regulatory Data
Event ID
82296
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
AVKARE Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Jan 14, 2020
Product Description
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-634-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Batch or Lot Expiration Information
Lot# Lots: a) 22738 Exp. 07/2020 and b) 22739 Exp. 07/2020
Affected Packages Involved in this Recall
42291-633-01Product
42291-633-50Product
42291-634-01Product
42291-634-50Product
42291-635-01Product
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.
