D-0335-2024 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
4,932 boxes

Product Description

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.

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