Drug product
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
D-0038-2024
Product summary
- Event
- Event 93100
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,248 bottles
- Official record key
drug-enforcement:D-0038-2024
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot#: M300652 and M300651, exp. Dec 2024
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications