D-0335-2024 Class I Ongoing
FDA drug recall D-0335-2024 was initiated by Neptune Resources, LLC on January 12, 2024 and is designated Class I. 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. The recall status is ongoing. Affected quantity: 4,932 boxes.
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