Recall Enforment Report D-0335-2024
Recall Details
Multi event Drug Recall Enforcement Report Class I voluntary initiated by Neptune Resources, LLC, originally initiated on 01-12-2024 for the product 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. The product was recalled due to marketed without an approved nda/anda: product contains tianeptine, a substance not fda-approved for any medical use in the united states.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
---|---|---|---|---|---|---|---|
D-0335-2024 | 01-12-2024 | 02-28-2024 | Class I | 4,932 boxes | 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. | Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States. | Ongoing |
D-0333-2024 | 01-12-2024 | 02-28-2024 | Class I | 1,000,000 bottles | 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. | Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States. | Ongoing |
D-0334-2024 | 01-12-2024 | 02-28-2024 | Class I | 117,000 bottles | Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801. | Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States. | Ongoing |