Drug product

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

D-0096-2024

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-0096-2024

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: M212749, exp. date 11/2024; M214477, exp. date 11/2024; M214478, exp. date 11/2024; M214479, exp. date 11/2024; M214480, exp. date 11/2024

Distribution pattern: Nationwide.

Derived failure modes

Potency or specification failure
reason.potency_specification_failure · v1.0.0

out-of-specification