Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Inventia Healthcare Limited | Thane, India | Makes it | Problems found, fixed voluntarilyFeb 12, 2025 · 4 inspections |
| Zydus Lifesciences Limited | Ankleshwar, India | Makes the active ingredient, tests it, packages it and labels it | No problems foundMar 14, 2025 · 4 inspections |
Recalls
- Oct 19, 2016 · Class II · Inventia Healthcare Private Limited
Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30s opening. First report came in June 14, 2016. Till date about 22 reports have come in from pharmacies which report two batches 130/16/001 and 130/16/002. Third batch 130/16/003 is not distributed yet, will be recalled from warehouse.
Lots: Batch # 130/16/001, 130/16/002, 130/16/003; Exp. Date 10/17
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
- Strength
- 30 mg
- Approval
- ANDA ANDA202336
- On the market since
- Dec 5, 2015
- Package NDCs
69097-298-0269097-298-0369097-298-0569097-298-15- Official label
- DailyMed (National Library of Medicine), updated Apr 26, 2016
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