NDC 47335-579
Lurasidone Hydrochloride 120 mg tablet
On the label: Caraco Pharmaceutical Laboratories, Ltd..
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
- 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 #: DNE0620A Exp. 05/31/2025 - 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: DNE0621A Exp. 11/30/2024, DNE0815A Exp. 12/31/2024
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Lurasidone: every company that makes it
- Form
- tablet, oral
- Strength
- 120 mg
- Approval
- ANDA ANDA208066
- On the market since
- Feb 20, 2023
- Package NDCs
47335-579-1347335-579-8147335-579-83- Official label
- DailyMed (National Library of Medicine), updated Jun 1, 2026
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