Neptune Resources, LLC recalls Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N.…

Recall date

January 12, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0333-2024

FDA classification

Class I

Brand / firm

Neptune Resources, LLC

Sold / distributed

Nationwide in the USA

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.