Why it was recalled
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
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.
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0335-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Jan 12, 2024
- FDA report date
- Feb 28, 2024
- Quantity
- 4,932 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Neptune Resources, LLC
Original FDA data
Every field from FDA enforcement report D-0335-2024, exactly as published.
Show all FDA fields
- City
- Kansas City
- State
- MO
- Status
- Ongoing
- Country
- United States
- Event ID
- 93808
- Address
- 1324 W 12th St Fl 5
- Code information
- All lots
- Postal code
- 64101-1343
- Report date
- Feb 28, 2024
- Product type
- Drugs
- Recall number
- D-0335-2024
- Classification
- Class I
- Recalling firm
- Neptune Resources, LLC
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jan 12, 2024
- Initial firm notification
- Letter
- Center classification date
- Feb 16, 2024