FDA recall D-0333-2024

Product

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.

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

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2024-01-12

Report date

2024-02-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kansas City, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0333-2024