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Breckenridge Pharmaceutical, Inc.

Pharmaunternehmen3 erfasste Produkte
3
erfasste Produkte
79.173
Meldungen insgesamt
11
dokumentierte Rückrufe
86,7%
schwerwiegend insgesamt
Produkte
3 von 3 angezeigt
ProduktZugelassenMeldungen ↓Top-SignalRückrufe
200950.182Lebermetastasen6
—16.333Polyomavirus-assoziierte Nierenerkrankung5
201212.658Rheumatisches Fieber0
Rückrufhistorie · 21 dokumentiert
DatumKlasseGrundFirma
4. Juni 2026IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limitBreckenridge Pharmaceutical, Inc.
4. Juni 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. Sept. 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. Juli 2025IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.Breckenridge Pharmaceutical, Inc.
15. Juli 2025IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limitBreckenridge Pharmaceutical, Inc.
30. Juni 2025IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limitBreckenridge Pharmaceutical, Inc.
26. März 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

Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.

Registrierungsstatus

Einige Produkte von Breckenridge Pharmaceutical, Inc. sind nicht für die Anwendung am Menschen FDA-registriert. Für nicht registrierte Substanzen (Peptide, SARMs ohne Humanzulassung) existiert kein legitimer Anbieter für die Anwendung am Menschen. Das Fehlen eines Bezugswegs ist die Sicherheitsinformation.