Product: DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.
Reason for recall: cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Recall initiated: 20190424
Status: Terminated
Classification: Class II
Recall type: N/A