D-0393-2024 Class I Terminated
FDA drug recall D-0393-2024 was initiated by Super Chill Products on February 5, 2024 and is designated Class I. 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. The recall status is terminated (terminated August 20, 2024). Affected quantity: 3,573 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 27, 2024
- Initiation Date
- February 5, 2024
- Termination Date
- August 20, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,573 bottles
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.
Distribution Pattern
Nationwide in the U.S.
Code Information
All lots within expiry