Breckenridge Pharmaceutical, Inc.

27 FDA enforcement actions

27 Total Recalls

0 Class I

27 Class II

0 Class III

Firm Details

Product Types: drug
States: NJ, CT

All Recalls

Class II: Risk 11/24/2025 drug

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

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

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

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

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II: Risk 07/15/2025 drug

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Class II: Risk 06/30/2025 drug

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II: Risk 04/14/2025 drug

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II: Risk 04/14/2025 drug

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II: Risk 03/26/2025 drug

CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Class II: Risk 02/28/2025 drug

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II: Risk 02/28/2025 drug

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II: Risk 02/28/2025 drug

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II: Risk 12/06/2024 drug

CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II: Risk 12/06/2024 drug

CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II: Risk 10/10/2024 drug

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II: Risk 05/17/2024 drug

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II: Risk 04/29/2024 drug

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II: Risk 04/29/2024 drug

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II: Risk 04/29/2024 drug

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II: Risk 03/02/2023 drug

CGMP Deviations: Potential risk of Cross Contamination
Class II: Risk 03/02/2023 drug

CGMP Deviations: Potential risk of Cross Contamination
Class II: Risk 03/02/2023 drug

CGMP Deviations: Potential risk of Cross Contamination
Class II: Risk 03/02/2023 drug

CGMP Deviations: Potential risk of Cross Contamination
Class II: Risk 03/02/2023 drug

CGMP Deviations: Potential risk of Cross Contamination
Class II: Risk 03/02/2023 drug

CGMP Deviations: Potential risk of Cross Contamination
Class II: Risk 03/11/2021 drug

Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.

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.