FDA recall D-0097-2024

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.

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.

Key facts

Status

Completed

Initiation date

2023-10-19

Report date

2023-11-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0097-2024