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.
PremierZen Platinum 5000, Packaged in paper packaging with a pill blister, 1 capsule per box, Distributed by New Premier Group Los Angeles CA 90006
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Reason Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Reason Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety…
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
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