Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | Dadra, India | Makes it and tests it | Problems found, fixed voluntarilyMar 29, 2019 · 5 inspections |
Recalls
- Jul 18, 2023 · Class III · Sun Pharmaceutical Industries Inc
Out of Specification result observed in content uniformity testing
Lots: Lot: DNE0217A, Exp 01/2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Dofetilide: every company that makes it
- Form
- capsule, oral
- Strength
- 0.5 mg
- Approval
- ANDA ANDA210466
- On the market since
- Oct 11, 2018
- Package NDCs
47335-063-6647335-063-7947335-063-86- Official label
- DailyMed (National Library of Medicine), updated Nov 1, 2023
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