Aurobindo Pharma USA Inc.: Drug Recall

Recall #D-1171-2023 · 08/02/2023

Class II: Risk

Recall Details

Recall Number: D-1171-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Aurobindo Pharma USA Inc.
Status: Terminated
Date Initiated: 08/02/2023
Location: East Windsor, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 9,890 bottles

Reason for Recall

Failed dissolution specifications - results obtained were below spec average.

Product Description

Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93

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.