Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superc...
FDA Recall #D-0393-2024 — Class I — February 5, 2024
Product Description
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.
Recalling Firm
Super Chill Products — New York, NY
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
3,573 bottles
Distribution
Nationwide in the U.S.
Code Information
All lots within expiry
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated