Drug recall D-0096-2024
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
Reason for recall
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Lots and codes
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
Recall details
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
- Distribution
- Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 19, 2023
Related products
- Oxybutynin – drug information
- NDC 68382-255 Oxybutynin · Oxybutynin Chloride 5 mg/1 · Zydus Pharmaceuticals USA Inc.
- NDC 68382-257 Oxybutynin · Oxybutynin Chloride 15 mg/1 · Zydus Pharmaceuticals USA Inc.
- NDC 68382-256 Oxybutynin · Oxybutynin Chloride 10 mg/1 · Zydus Pharmaceuticals USA Inc.