Product: Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by:  Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-617-08
Reason for recall: cGMP deviations: Batch was released prior to approval.
Recall initiated: 20230721
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated