Drug Enforcement 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.

Status

Terminated

Classification

Class I

Report Date

March 27, 2024

Termination Date

August 20, 2024

Product Information

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.
Product quantity
3,573 bottles
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 initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the U.S.

Location & Firm

Recalling firm
Super Chill Products
Address
827 6th Ave

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0393-2024
Event ID
93946
Recall initiation date
February 5, 2024
Center classification date
March 21, 2024
Code info
All lots within expiry
More code info
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