Class II · Moderate risk
Triple SupremeZen Plus 3500
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
PremierZen Extreme 3000
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
What was recalled
PremierZen Extreme 3000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
- Recalling firm
- Hyobin LLC
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0381-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other recalls by Hyobin LLC
All 2021 recalls
Class II · Moderate risk
PremierZen Black 5000
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Other chemical / undeclared recalls from 2021
All chemical / undeclared recalls
Class II · Moderate risk
Secret Dry Spray
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk
Secret
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk
Secret
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk
Secret
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
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