Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-255-01
Reported: November 15, 2023 Initiated: October 19, 2023 #D-0096-2024
Product Description
Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-255-01
Reason for Recall
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Details
- Recalling Firm
- Zydus Pharmaceuticals (USA) Inc
- Distribution
- Nationwide.
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-255-01. Recalled by Zydus Pharmaceuticals (USA) Inc.
Why was this product recalled? ▼
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 15, 2023. Severity: Moderate. Recall number: D-0096-2024.
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