NDC 62756-224
Tiagabine Hydrochloride 4 mg tablet, film coated
On the label: Caraco Pharmaceutical Laboratories, Ltd..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | Halol, India | Makes it and tests it | Serious problems, FDA actionJun 13, 2025 · 12 inspections, 5 with FDA action |
Recalls
- Jul 10, 2023 · Class II · Sun Pharmaceutical Industries Inc
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Lots: Lot HAC3339A, Expires 07/2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Tiagabine: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 4 mg
- Approval
- ANDA ANDA077555
- On the market since
- Nov 4, 2011
- Package NDCs
62756-224-0862756-224-1862756-224-8362756-224-88- Official label
- DailyMed (National Library of Medicine), updated Nov 2, 2018
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