Aurobindo Pharma USA Inc.: Drug Recall

Recall #D-1088-2023 · 07/21/2023

Class II: Risk

Recall Details

Recall Number: D-1088-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Aurobindo Pharma USA Inc.
Status: Terminated
Date Initiated: 07/21/2023
Location: East Windsor, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 48 bottles

Reason for Recall

cGMP deviations: Batch was released prior to approval.

Product Description

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

Distribution Pattern

USA nationwide

Other Recalls by Aurobindo Pharma USA Inc.

Class II: Risk 05/22/2025

cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Class II: Risk 12/06/2024

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Class II: Risk 11/07/2024

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II: Risk 11/07/2024

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II: Risk 11/07/2024

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

View all recalls by Aurobindo Pharma USA Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.