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D-0393-2024Class I

Super Chill Products

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Super Chill Products
Product type
Drug
Status
Terminated
Report date
2024-03-27
Distribution
Nationwide in the U.S.
Firm state
NY
Product quantity
3,573 bottles
Initiated by
Voluntary: Firm initiated
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.

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.

Code / lot info

All lots within expiry

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →