Breckenridge Pharmaceutical, Inc.
Overview
Breckenridge Pharmaceutical, Inc. is a subsidiary of Towa Pharmaceutical Co., Ltd., providing a variety of high-quality generic pharmaceutical products. The company focuses on delivering value and quality to meet the needs of patients and healthcare professionals.
API / Drug Master Files
Breckenridge Pharmaceutical, Inc. holds 1 active (1 total) FDA Type II Drug Master File — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- ETHACRYNIC ACID USPActive2013-09-03
FDA compliance signals
35 FDA enforcement records linked to this company.
- recall — Class II2026-05-13
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- recall — Class II2025-12-10
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- recall — Class II2025-12-10
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- recall — Class II2025-11-05
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
- recall — Class II2025-09-17
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
- recall — Class II2025-08-20
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
- recall — Class II2025-08-13
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
- recall — Class II2025-07-16
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- recall — Class II2025-04-30
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- recall — Class II2025-04-30
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- recall — Class II2025-04-09
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
- recall — Class II2025-03-19
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
- recall — Class II2025-03-19
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
- recall — Class II2025-03-19
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
- recall — Class II2025-01-01
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
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