Zydus Pharmaceuticals (USA) Inc: Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmace

Hazard

Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.

Details from the source

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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.