Status
Ongoing
Drug Enforcement D-0335-2024
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Classification
Class I
Report Date
February 28, 2024
Termination Date
—
Product Information
- 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.
- Product quantity
- 4,932 boxes
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Neptune Resources, LLC
- Address
-
1324 W 12th St Fl 5, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0335-2024
- Event ID
- 93808
- Recall initiation date
- January 12, 2024
- Center classification date
- February 16, 2024
- Code info
- All lots
- More code info
- —