FDA-Drug2023-11-15Class II
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.
Zydus Pharmaceuticals (USA) Inc
Hazard
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Sold states
Nationwide.
Manufactured in
73 Route 31 N, Pennington, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0097-2024Don't want to check this manually?
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