FDARecalled Nov 15, 2023 · #D-0096-2024
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...
Hazard
Class II — temporary health risk
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Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point. Classification: Class II Distribution: Nationwide.
Product details
- 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
- Type
- Drugs
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Model numbers
- —
- UPCs
- —