Drug product
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.
D-0097-2024
Product summary
- Event
- Event 93260
- Status
- Completed
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0097-2024
Official wording
Reason: Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Code information: 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
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
out-of-specification