Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India NDC 55111-533-01
Recall Number: D-0507-2019
Firm: Dr. Reddy's Laboratories, Inc.
Classification: Class II
Status: Terminated
Report Date: 20190227
Initiation Date: 20190131
Termination Date: 20230214
Reason for Recall
Failed Dissolution Specifications: Out of specification results observed for high dissolution.
Product Description
Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India NDC 55111-533-01