NDC 0904-7495
Omega-3-Acid Ethyl Esters 1 g capsule, liquid filled
On the label: Major Pharmaceuticals. It's repackaged: Major Pharmaceuticals rebottles it from Lifestar Pharma LLC.'s NDC 70756-423.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Softgel Healthcare Private Limited | Chengalpattu, India | Makes it, tests it and packages it | Problems found, fixed voluntarilyFeb 14, 2025 · 4 inspections |
Recalls
- Apr 9, 2026 · Class II · The Harvard Drug Group LLC
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Lots: Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Omega-3 Fatty Acids: every company that makes it
- Form
- capsule, liquid filled, oral
- Strength
- 1 g
- Approval
- ANDA ANDA215458
- On the market since
- Dec 13, 2024
- Package NDCs
0904-7495-06- Official label
- DailyMed (National Library of Medicine), updated May 21, 2026
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