Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA
Recall Number: D-1133-2019
Firm: Dr. Reddy's Laboratories, Inc.
Classification: Class II
Status: Terminated
Report Date: 20190424
Initiation Date: 20190411
Termination Date: 20200625
Reason for Recall
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Product Description
Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA