Anti-epileptic Agent
Where is Tiagabine made?
2 companies sell it under their own name and 2 repackagers rebottle it. Their labels name 2 factories in India.
India 2
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Caraco Pharmaceutical Laboratories, Ltd.2 mg, 4 mg · NDC 62756-200, 62756-224 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Halol, India | Serious problems, FDA actionJun 2025 |
| Novadoz Pharmaceuticals LLC2 mg, 4 mg, 12 mg, 16 mg · NDC 72205-086, 72205-087, 72205-084 +1 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
Repackaged by
These companies buy Tiagabine in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- Carilion Materials Management:
68151-4235 - Stat Rx USA:
16590-832
Recalls
- Jul 10, 2023 · Class II · Sun Pharmaceutical Industries Inc
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.