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

Recall Number: D-1088-2023

Firm: Aurobindo Pharma USA Inc.

Classification: Class II

Status: Terminated

Report Date: 20230830

Initiation Date: 20230721

Termination Date: 20240226

cGMP deviations: Batch was released prior to approval.

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