Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054, NDC 68382-031-01

Recall Number: D-1041-2017

Firm: Zydus Pharmaceuticals USA Inc

Classification: Class II

Status: Terminated

Report Date: 20170809

Initiation Date: 20170510

Termination Date: 20200107

Failed Dissolution Specifications

Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054, NDC 68382-031-01