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Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured ...

FDA Recall #D-0097-2024 — Class II — October 19, 2023

Recall #D-0097-2024 Date: October 19, 2023 Classification: Class II Status: Completed

Product Description

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.

Recalling Firm

Zydus Pharmaceuticals (USA) Inc — Pennington, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Distribution

Nationwide.

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

Status

Completed

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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