NDC 60687-538
Febuxostat 40 mg tablet, film coated
On the label: American Health Packaging. It's repackaged: American Health Packaging rebottles it from Caraco Pharmaceutical Laboratories, Ltd.'s NDC 47335-721.
Where the pills inside were 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 |
Repackaging site
- American Health Packaging, Columbus, OH, United States · repackages it
Recalls
- Jan 25, 2024 · Class II · Amerisource Health Services LLC
CGMP Deviations
Lots: Lot # 1015033, exp. 06/30/2025; 1016409, exp. 08/31/2025 - Jan 18, 2024 · Class II · Sun Pharmaceutical Industries Inc
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lots: Lot #s: DNE0866B Exp. 06/30/2025, DNE1045A, DNE1046B Exp. 08/31/2025 - Jan 18, 2024 · Class II · Sun Pharmaceutical Industries Inc
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lots: Lot #s: DNE0867A Exp. 06/30/2025, DNE0894B Exp. 07/31/2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Febuxostat: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 40 mg
- Approval
- ANDA ANDA205467
- On the market since
- Sep 2, 2021
- Package NDCs
60687-538-1160687-538-21- Official label
- DailyMed (National Library of Medicine), updated Jan 30, 2024
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