Product: Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054
Reason for recall: Failed Dissolution Specifications
Recall initiated: 20170510
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated