Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Torrent Pharmaceuticals Limited | Indrad, India | Makes it, tests it and packages it | Problems found, fixed voluntarilyJun 12, 2024 · 7 inspections, 2 with FDA action |
| Torrent Pharmaceuticals Limited | Bharuch, India | Makes it, tests it and packages it | No problems foundJan 23, 2026 · 5 inspections, 1 with FDA action |
Recalls
- May 27, 2025 · Class II · Torrent Pharma Inc.
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Lots: Lot# BDX6K001; Exp. Date 06/30/2025 - May 27, 2025 · Class II · Torrent Pharma Inc.
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Lots: Lot# BDX6K001; Exp. Date: 06/30/2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Fluoxetine: every company that makes it
- Form
- tablet, oral
- Strength
- 20 mg
- Approval
- ANDA ANDA206937
- On the market since
- Oct 21, 2016
- Package NDCs
13668-473-0113668-473-1013668-473-3013668-473-7413668-473-91- Official label
- DailyMed (National Library of Medicine), updated Oct 19, 2026
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