FDA recall D-0393-2024

Product

Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th Avenue, New York, New York 10001.

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 U.S.

Key facts

Status

Terminated

Initiation date

2024-02-05

Report date

2024-03-27

Termination date

2024-08-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0393-2024