Breckenridge Pharmaceutical, Inc: Drug Recall

Recall #D-0463-2023 · 03/02/2023

Class II: Risk

Recall Details

Recall Number: D-0463-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Breckenridge Pharmaceutical, Inc
Status: Terminated
Date Initiated: 03/02/2023
Location: Berlin, CT, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

Reason for Recall

CGMP Deviations: Potential risk of Cross Contamination

Product Description

Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037, NDC 51991-901-01

Distribution Pattern

USA nationwide.

Other Recalls by Breckenridge Pharmaceutical, Inc

Class II: Risk 11/24/2025

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II: Risk 11/24/2025

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II: Risk 10/09/2025

CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Class II: Risk 08/08/2025

CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Class II: Risk 07/25/2025

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

View all recalls by Breckenridge Pharmaceutical, 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.