Ajanta Pharma Limited
Chhatrapati Sambhajinagar, India · makes it
Problems found, fixed voluntarily Last FDA inspection Apr 21, 2026. 6 inspections on record.
NDC 50436-0198
Duloxetine 30 mg capsule, delayed release
On the label: Unit Dose Services.
It's a repackaged product: Unit Dose Services rebottles it from Ajanta Pharma USA Inc.'s NDC 27241-098.
Where the pills inside were made
Ajanta Pharma Limited
Bharuch, India · makes it
No problems found Last FDA inspection Jun 23, 2023. 3 inspections on record.
Repackaging site
- Unit Dose Services, · repackages it and relabels it
Recalls
- Apr 29, 2026 · Class II · Ongoing
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 · Ongoing
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 · Ongoing
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.
Product details
- Generic drug
- Duloxetine: see every company that makes it
- Form
- capsule, delayed release
- Strength
- 30 mg
- Approval
- ANDA ANDA208706
- On the market since
- Mar 16, 2017
- Package NDCs
50436-0198-150436-0198-2- Official label
- DailyMed (National Library of Medicine), updated Aug 24, 2021
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