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

FDA recall notice · announced June 30, 2021 · Miracle 8989

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

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

Reason for recall

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

Notes

Distribution: USA Nationwide
Lot/code information: All lots remaining within expiry.
Quantity: Unknown
Status: Terminated
Products in this recall event:
- maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), Distributed by: Maxx Inc, Los Angeles, CA 90028 (D-0635-2021)
- PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006 (D-0633-2021)
- 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 (D-0634-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.