D-0333-2024 Class I Ongoing

Recalled by Neptune Resources, LLC — Kansas City, MO

Recall Details

Product Type
Drugs
Report Date
February 28, 2024
Initiation Date
January 12, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,000,000 bottles

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

All lots