Class II Recall

Aurobindo Pharma USA Inc.

Product
Rufinamide Tablets, USP 200 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 59651-616-08
Reason
cGMP deviations: Batch was released prior to approval.
Classification
Class II
Status
Terminated
Lot
Lot #: RB2023001A, Exp 02/2025
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.