Skip to content
Recall Observatory FDA recall evidence

Drug 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.

D-0098-2024

October 19, 2023

Class II

Product summary

Firm
Zydus Pharmaceuticals (USA) Inc
Event
Event 93260
Status
Completed
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-0098-2024

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: M211541, exp. date 10/2024 M211542, exp. date 10/2024 M212746, exp. date 10/2024 M300660, exp. date 12/2024

Distribution pattern: Nationwide.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out-of-specification