Drug & medication recalls Moderate risk

Hyobin LLC recalls Triple SupremeZen Plus 3500, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio…

Recall date
April 6, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0383-2021
FDA classification
Class II
Brand / firm
Hyobin LLC
Sold / distributed
USA Nationwide

Why it was recalled

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Triple SupremeZen Plus 3500, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ

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