Oxybutynin Chloride Extended-Release Tablet USP recall: Failed Dissolution
Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-257-01.
Why was Oxybutynin Chloride Extended-Release Tablet USP recalled?
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
M211541, exp. date 10/2024 M211542, exp. date 10/2024 M212746, exp. date 10/2024 M300660, exp. date 12/2024
- Product
- Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-257-01.
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Distribution
- Nationwide.
- Recall date
- November 15, 2023
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (drug)