Drug & medication recalls High risk

Super Chill Products recalls Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th…

Recall date
February 5, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0393-2024
FDA classification
Class I
Brand / firm
Super Chill Products
Sold / distributed
Nationwide in the U.S.

Why it was recalled

Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.

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