Drug product
Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th Avenue, New York, New York 10001.
D-0393-2024
Product summary
- Event
- Event 93946
- Status
- Terminated
- Classification
- Class I
- Quantity
- 3,573 bottles
- Official record key
drug-enforcement:D-0393-2024
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 within expiry
Distribution pattern: Nationwide in the U.S.
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.