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Breckenridge Pharmaceutical, Inc.

Farmaceutisch bedrijf3 producten gevolgd
3
producten gevolgd
79.173
totaal meldingen
11
recalls geregistreerd
86,7%
ernstig algeheel
Producten
3 van 3 getoond
ProductGoedgekeurdMeldingen ↓Top signaalRecalls
200950.182uitzaaiingen naar lever6
—16.333polyomavirus-geassocieerde nefropathie5
201212.658reumatische koorts0
Recall-geschiedenis · 21 geregistreerd
DatumKlasseRedenBedrijf
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 apr 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 okt 2025IIIFailed Impurities/Degradation Specifications: Out of specification for impurity IP-C.Endo USA, Inc.
10 okt 2025IIIFailed Impurities/Degradation Specifications: Out of specification for impurity IP-C.Endo USA, Inc.
10 okt 2025IIIFailed Impurities/Degradation Specifications: Out of specification for impurity IP-C.Endo USA, Inc.
10 okt 2025IIIFailed Impurities/Degradation Specifications: Out of specification for impurity IP-C.Endo USA, Inc.
9 okt 2025IICGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.Breckenridge Pharmaceutical, Inc.
5 sep 2025IIIFailed Impurities/Degradation Specifications: Out of specification for impurity IP-C.Endo USA, Inc.
8 aug 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 mrt 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

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Registratiestatus

Sommige producten van Breckenridge Pharmaceutical, Inc. zijn niet FDA-geregistreerd voor humaan gebruik. Voor ongeregistreerde stoffen (peptiden, SARMs zonder humane registratie) bestaat geen legitieme leverancier voor humaan gebruik. Het ontbreken van een inkooproute is de veiligheidsinformatie.