Product: 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
Reason for recall: cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Recall initiated: 20190411
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated