Class II
Completed
Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-256-01.
- Company
- Zydus Pharmaceuticals (Usa) Inc
- Recall Initiated
- October 19, 2023
- Posted
- November 15, 2023
- Recall Number
- D-0097-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Pennington, NJ, United States
Reason for Recall
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Distribution
Nationwide.
Lot / Code Info
M213318, exp. date 11/2024; M213314, exp. date 11/2024; M213315, exp. date 11/2024; M214436, exp. date 11/2024; M214437, exp. date 11/2024; M214438, exp. date 11/2024; M300653, exp. date 12/2024; M300654, exp. date 12/2024
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