NDC 45865-815
DuloxetineDelayed-Release 20 mg capsule, delayed release pellets
On the label: Medsource Pharmaceuticals. It's repackaged: Medsource Pharmaceuticals rebottles it from Breckenridge Pharmaceutical, Inc.'s NDC 51991-746.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Towa Pharmaceutical Europe, S.L. | Martorelles, Spain | Makes it | Problems found, fixed voluntarilySep 9, 2022 · 6 inspections |
| Apace Packaging LLC | Fountain Run, KY, United States | Packages it | No problems foundJan 13, 2022 · 6 inspections |
Repackaging site
- Medsource Pharmaceuticals, Rancho Santa Margarita, CA, United States · repackages it
Recalls
- Jun 4, 2026 · Class II · Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Lots: Lot: 241180C, Exp. Date April 2027. - Jun 4, 2026 · Class II · Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Lots: Lot: a) 241074C, Exp. Date May 2027; 240317, 240318, 240315C, 240373C, 240370C, 240375C, 240413C, Exp. Date February 2027; 240316,Exp. Date January 2027; 232311, Exp. Date November 2026; b) 240978C, 241052C, Exp. Date April 2027. - Apr 21, 2026 · Class II · Breckenridge Pharmaceutical, Inc.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Lots: Lot: 241069C, Exp 05/31/2027 - Nov 24, 2025 · Class II · Breckenridge Pharmaceutical, Inc.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Lots: Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027. - Oct 9, 2025 · Class II · Breckenridge Pharmaceutical, Inc.
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Lots: 90-count- Lot # 240721C; Exp. 02/28/2027 1000-count- Lot #230286C; Exp.02/28/2026 - Jul 15, 2025 · Class II · Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Lots: Lot: 230836C, Exp.: 02/28/2026 - Jun 30, 2025 · Class II · Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Lots: Lot # 230199, Exp. Date 01/31/2026 - Apr 14, 2025 · Class II · Breckenridge Pharmaceutical, Inc
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Lots: Lot # 240987C, exp. date 04/2027 241014C, exp. date 04/2027 - Apr 14, 2025 · Class II · Breckenridge Pharmaceutical, Inc
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Lots: Lot # 230201C, exp. date 01/2026 230471C, exp. date 01/2026 230288C, exp. date 01/2026 - Mar 26, 2025 · Class II · Breckenridge Pharmaceutical, Inc.
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Lots: Lot 240909C, Exp Date 03/31/2027 - Feb 28, 2025 · Class II · Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Lots: Lot#: 240301C, Expiration: 01/2027. - Feb 28, 2025 · Class II · Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Lots: Lot#: 240225C, Expiration: 01/2027 - Feb 28, 2025 · Class II · Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Lots: Lot#: 240098C, Expiration: 01/2027. - Dec 6, 2024 · Class II · Breckenridge Pharmaceutical, Inc
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Lots: Lot # 222205C, exp. date 11/2025 - Dec 6, 2024 · Class II · Breckenridge Pharmaceutical, Inc
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Lots: Lot # 230077C, exp. date 11/2025 - Oct 10, 2024 · Class II · Breckenridge Pharmaceutical, Inc
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Lots: Lot #: 220128, Exp. Date 12/2024 - May 17, 2024 · Class II · Breckenridge Pharmaceutical, Inc
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Lots: Lot #: 230035C, Exp. date 11/30/2025; 230101C, Exp. date 12/31/2025 - Apr 29, 2024 · Class II · Breckenridge Pharmaceutical, Inc
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Lots: 220265: Exp. Feb 2025 220088: Exp. Nov 2024 220267: Exp. Feb 2025 220256: Exp. Feb 2025 220225: Exp. Jan 2025 220269: Exp. Feb 2025 - Apr 29, 2024 · Class II · Breckenridge Pharmaceutical, Inc
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Lots: 220456: Exp. Feb 2025 - Apr 29, 2024 · Class II · Breckenridge Pharmaceutical, Inc
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Lots: 230028C: Exp. Nov 2025 230106C: Exp. Dec 2025 230170C: Exp. Dec 2025 220039: Exp. Dec 2024 220363: Exp. Feb 2025 - Oct 21, 2015 · Class III · Breckenridge Pharmaceutical, Inc
Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
Lots: Lot #: 142391, Exp 10/2016
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Duloxetine: every company that makes it
- Form
- capsule, delayed release pellets
- Strength
- 20 mg
- Approval
- ANDA ANDA203088
- On the market since
- Jun 11, 2014
- Package NDCs
45865-815-3045865-815-60- Official label
- DailyMed (National Library of Medicine), updated Dec 24, 2018
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