NDC 85534-0052
Duloxetine 30 mg capsule, delayed release
On the label: Hawaii Repack, Inc.. It's repackaged: Hawaii Repack, Inc. rebottles it from Ajanta Pharma USA Inc.'s NDC 27241-098.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Ajanta Pharma Limited | Chhatrapati Sambhajinagar, India | Makes it | Problems found, fixed voluntarilyApr 21, 2026 · 6 inspections |
| Ajanta Pharma Limited | Bharuch, India | Makes it | No problems foundJun 23, 2023 · 3 inspections |
Recalls
- Apr 29, 2026 · Class II · Ajanta Pharma Ltd.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Lots: Lot#: a) PA10774, Exp. May 2026; b) PA10794, PA12174, Exp. Jun 2026; c) PA10804, Exp. Jun-26. - Apr 29, 2026 · Class II · Ajanta Pharma Ltd.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Lots: Lot#: PA07434, Exp. May 2026. - Apr 29, 2026 · Class II · Ajanta Pharma Ltd.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Lots: Lot#: PA10734, Exp. Jun 2026.
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, oral
- Strength
- 30 mg
- Approval
- ANDA ANDA208706
- On the market since
- Mar 16, 2017
- Package NDCs
85534-0052-085534-0052-185534-0052-285534-0052-3- Official label
- DailyMed (National Library of Medicine), updated Sep 9, 2026
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