HealthProves
Home/Manufacturers/Breckenridge Pharmaceutical, Inc.
Manufacturer profile

Breckenridge Pharmaceutical, Inc.

Pharmaceutical company3 products tracked
3
products tracked
79,173
total reports
11
recalls on record
86.7%
serious overall
Products
showing 3 of 3
ProductApprovedReports ↓Top signalRecalls
200950,182Metastases to liver6
—16,333Polyomavirus-associated nephropathy5
201212,658Rheumatic fever0
Recall history · 21 on record
DateClassReasonFirm
Jun 4, 2026IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limitBreckenridge Pharmaceutical, Inc.
Jun 4, 2026IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limitBreckenridge Pharmaceutical, Inc.
Apr 21, 2026IICGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limitBreckenridge Pharmaceutical, Inc.
Nov 24, 2025IICGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limitBreckenridge Pharmaceutical, Inc.
Nov 24, 2025IICGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limitBreckenridge Pharmaceutical, Inc.
Oct 10, 2025IIIFailed Impurities/Degradation Specifications: Out of specification for impurity IP-C.Endo USA, Inc.
Oct 10, 2025IIIFailed Impurities/Degradation Specifications: Out of specification for impurity IP-C.Endo USA, Inc.
Oct 10, 2025IIIFailed Impurities/Degradation Specifications: Out of specification for impurity IP-C.Endo USA, Inc.
Oct 10, 2025IIIFailed Impurities/Degradation Specifications: Out of specification for impurity IP-C.Endo USA, Inc.
Oct 9, 2025IICGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.Breckenridge Pharmaceutical, Inc.
Sep 5, 2025IIIFailed Impurities/Degradation Specifications: Out of specification for impurity IP-C.Endo USA, Inc.
Aug 8, 2025IICGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.Breckenridge Pharmaceutical, Inc.
Jul 25, 2025IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.Breckenridge Pharmaceutical, Inc.
Jul 15, 2025IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limitBreckenridge Pharmaceutical, Inc.
Jun 30, 2025IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limitBreckenridge Pharmaceutical, Inc.
Mar 26, 2025IICGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.Breckenridge Pharmaceutical, Inc.
Feb 28, 2025IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.Breckenridge Pharmaceutical, Inc.
Feb 28, 2025IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.Breckenridge Pharmaceutical, Inc.
Feb 28, 2025IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.Breckenridge Pharmaceutical, Inc.
Nov 6, 2018IIIFailed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.Breckenridge Pharmaceutical, Inc.
Nov 14, 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

Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.

Registration status

Some products from Breckenridge Pharmaceutical, Inc. are not FDA-registered for human use. For unregistered substances (peptides, SARMs without human registration), no legitimate human-use supplier exists. The absence of a sourcing route is the safety information.