Triple SupremeZen Gold 3500
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
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.
PremierZen Platinum 5000, Packaged in paper packaging with a pill blister, 1 capsule per box, Distributed by New Premier Group Los Angeles CA 90006
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.
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
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