Recalls / Class II
Class IID-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
- Brand name
- Oxybutynin
- Generic name
- Oxybutynin
- Active ingredient
- Oxybutynin Chloride
- Route
- Oral
- NDCs
- 68382-255, 68382-256, 68382-257
- FDA application
- ANDA202332
- Affected lot / code info
- 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
Why it was recalled
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Recalling firm
- Firm
- Zydus Pharmaceuticals (USA) Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, Pennington, New Jersey 08534-3601
Distribution
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2023-10-19
- FDA classified
- 2023-11-08
- Posted by FDA
- 2023-11-15
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0096-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.