D-0038-2024 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 11, 2023
- Initiation Date
- September 21, 2023
- Termination Date
- August 6, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,248 bottles
Product Description
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-256-05) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
Nationwide in the USA.
Code Information
Lot#: M300652 and M300651, exp. Dec 2024