HealthProves
Accueil/Fabricants/Breckenridge Pharmaceutical, Inc.
Profil du fabricant

Breckenridge Pharmaceutical, Inc.

Société pharmaceutique3 produits suivis
3
produits suivis
79 173
total des notifications
11
rappels enregistrés
86,7%
graves au total
Produits
affichage de 3 sur 3
ProduitApprouvéNotifications ↓Signal principalRappels
200950 182métastases hépatiques6
—16 333Néphropathie associée aux polyomavirus5
201212 658fièvre rhumatismale0
Historique des rappels · 21 enregistrés
DateClasseMotifFabricant
4 juin 2026IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limitBreckenridge Pharmaceutical, Inc.
4 juin 2026IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limitBreckenridge Pharmaceutical, Inc.
21 avr. 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 août 2025IICGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.Breckenridge Pharmaceutical, Inc.
25 juil. 2025IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.Breckenridge Pharmaceutical, Inc.
15 juil. 2025IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limitBreckenridge Pharmaceutical, Inc.
30 juin 2025IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limitBreckenridge Pharmaceutical, Inc.
26 mars 2025IICGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.Breckenridge Pharmaceutical, Inc.
28 févr. 2025IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.Breckenridge Pharmaceutical, Inc.
28 févr. 2025IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.Breckenridge Pharmaceutical, Inc.
28 févr. 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

Classe I = probabilité raisonnable de préjudice grave · Classe II = temporaire ou réversible · Classe III = peu susceptible de causer un préjudice.

Statut d'enregistrement

Certains produits de Breckenridge Pharmaceutical, Inc. ne sont pas enregistrés auprès de la FDA pour un usage humain. Pour les substances non enregistrées (peptides, SARMs sans enregistrement humain), aucun fournisseur légitime à usage humain n'existe. L'absence de filière d'approvisionnement est l'information de sécurité.