Miracle 8989 recalls PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6), packaged in 12 cards per box (UPC 7 28175…

Recall date

May 18, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0634-2021

FDA classification

Class I

Brand / firm

Miracle 8989

Sold / distributed

USA Nationwide

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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