February 2024 FDA Recall Drug by Super Chill Products
D-0393-2024 - Marketed without an approved NDA/ANDA
This Class I drug recall was voluntarily initiated by Super Chill Products on February 5, 2024 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0393-2024
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
02-05-2024
03-27-2024
3,573 bottles
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Super Chill Products
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the U.S.
08-20-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# All lots within expiry
