FDAFDA · Food and drugs·Recall number D-0097-2024
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.
Published November 15, 2023 · Recall initiated: October 19, 2023
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- OXYBUTYNIN
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Distributor
- Nationwide.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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