Drug product

Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.

D-0334-2024

January 12, 2024

Class I

Product summary

Firm: Neptune Resources, LLC
Event: Event 93808
Status: Ongoing
Classification: Class I
Quantity: 117,000 bottles
Official record key: drug-enforcement:D-0334-2024

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
reason.no_named_rule · v1.0.0

Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.