NDC 82009-031
Duloxetine 40 mg capsule, delayed release pellets
On the label: Quallent Pharmaceuticals Health LLC.
Where it's 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 |
Recalls
- Nov 24, 2025 · Class II · Breckenridge Pharmaceutical, Inc.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Lots: Lot #: 240947C, 240962C, Exp. Date 04/2027 - Aug 8, 2025 · Class II · Breckenridge Pharmaceutical, Inc.
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Lots: Lot 240927C, Exp 04/30/2027 - Jul 25, 2025 · Class II · Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Lots: Lot 240539C, Exp 1/31/2027
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, oral
- Strength
- 40 mg
- Approval
- ANDA ANDA203088
- On the market since
- May 21, 2018
- Package NDCs
82009-031-3082009-031-90- Official label
- DailyMed (National Library of Medicine), updated Nov 3, 2025
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