PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ

FDA recall notice · announced May 26, 2021 · Hyobin

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ

Reason for recall

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

Notes

Distribution: USA Nationwide
Lot/code information: all lots
Quantity: 500 cards
Status: Ongoing
Products in this recall event:
- Triple SupremeZen Plus 3500, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ (D-0383-2021)
- PremierZen Extreme 3000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ (D-0381-2021)
- PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ (D-0382-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.