FDA-Drug2021-06-30Class I

PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6), packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006

Miracle 8989
Hazard

Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.

Sold states
USA Nationwide
Affected count
Unknown
Manufactured in
2001 W Northwest Hwy, N/A, Dallas, TX, United States
Products
PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6), packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0634-2021

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