Drug product
Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wide Awake, 3000 mg (150 mg Per Tablet), Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
D-0335-2024
Product summary
- Event
- Event 93808
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 4,932 boxes
- Official record key
drug-enforcement:D-0335-2024
Official wording
Reason: Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Code information: All lots
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.