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Breckenridge Pharmaceutical, Inc.

Compañía farmacéutica3 productos registrados
3
productos registrados
79.173
notificaciones totales
11
retiradas registradas
86,7%
graves en total
Productos
mostrando 3 de 3
ProductoAprobadoNotificaciones ↓Señal principalRetiradas
200950.182metástasis hepáticas6
—16.333Nefropatía asociada a poliomavirus5
201212.658fiebre reumática0
Historial de retiradas · 21 registradas
FechaClaseMotivoEmpresa
4 jun 2026IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limitBreckenridge Pharmaceutical, Inc.
4 jun 2026IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limitBreckenridge Pharmaceutical, Inc.
21 abr 2026IICGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limitBreckenridge Pharmaceutical, Inc.
24 nov 2025IICGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limitBreckenridge Pharmaceutical, Inc.
24 nov 2025IICGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limitBreckenridge Pharmaceutical, Inc.
10 oct 2025IIIFailed Impurities/Degradation Specifications: Out of specification for impurity IP-C.Endo USA, Inc.
10 oct 2025IIIFailed Impurities/Degradation Specifications: Out of specification for impurity IP-C.Endo USA, Inc.
10 oct 2025IIIFailed Impurities/Degradation Specifications: Out of specification for impurity IP-C.Endo USA, Inc.
10 oct 2025IIIFailed Impurities/Degradation Specifications: Out of specification for impurity IP-C.Endo USA, Inc.
9 oct 2025IICGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.Breckenridge Pharmaceutical, Inc.
5 sept 2025IIIFailed Impurities/Degradation Specifications: Out of specification for impurity IP-C.Endo USA, Inc.
8 ago 2025IICGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.Breckenridge Pharmaceutical, Inc.
25 jul 2025IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.Breckenridge Pharmaceutical, Inc.
15 jul 2025IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limitBreckenridge Pharmaceutical, Inc.
30 jun 2025IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limitBreckenridge Pharmaceutical, Inc.
26 mar 2025IICGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.Breckenridge Pharmaceutical, Inc.
28 feb 2025IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.Breckenridge Pharmaceutical, Inc.
28 feb 2025IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.Breckenridge Pharmaceutical, Inc.
28 feb 2025IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.Breckenridge Pharmaceutical, Inc.
6 nov 2018IIIFailed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.Breckenridge Pharmaceutical, Inc.
14 nov 2014IIPenicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.Attix Pharmaceuticals

Clase I = probabilidad razonable de daño grave · Clase II = temporal o reversible · Clase III = improbable que cause daño.

Estado de registro

Algunos productos de Breckenridge Pharmaceutical, Inc. no están registrados por la FDA para uso humano. Para las sustancias no registradas (péptidos, SARM sin registro humano) no existe ningún proveedor legítimo para uso humano. La ausencia de una vía de aprovisionamiento es la información de seguridad.