Recalling firm
Neptune Resources, LLC
Product type
Drug
Status
Ongoing
Report date
2024-02-28
Distribution
Nationwide in the USA
Firm state
MO
Product quantity
4,932 boxes
Initiated by
Voluntary: Firm initiated
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.
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.
Code / lot info
All lots
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.