FDA Recall D-0393-2024
Super Chill Products · New York, NY
Class I — life-threatening Terminated 197 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0393-2024- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the U.S.
- Recall initiated
- 2024-02-05
- Classified by FDA Center
- 2024-03-21
- FDA published
- 2024-03-27
- Terminated
- 2024-08-20
- Recalling firm
- Super Chill Products
- Firm location
- New York, NY