NDC 71335-2017

Duloxetine 30 mg capsule, delayed release

On the label: Bryant Ranch Prepack. It's repackaged: Bryant Ranch Prepack 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

Bryant Ranch Prepack, Burbank, CA, United States · repackages it and relabels it

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.

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: 71335-2017-1 71335-2017-2 71335-2017-3 71335-2017-4 71335-2017-5 71335-2017-6 71335-2017-7 71335-2017-8
Official label: DailyMed (National Library of Medicine), updated Aug 7, 2024

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