The Recall Desk

FDA (Drugs) recall action 87981

Miracle 8989 recalled 3 products on 2021-06-30

The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2021-06-30
Critical
1
Units
—

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

1–3 of 3

  • CriticalFDA (Drugs)··2021-06-30

    PremierZEN Platinum 8000 Capsules Recalled for Undeclared Drug Ingredients

    PremierZEN Platinum 8000 capsules, distributed nationwide, are being recalled because the product contains undeclared pharmaceutical ingredients (Sildenafil and Tadalafil) and was marketed without FDA approval.

    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
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-06-30

    maXXzen Platinum 12000 Capsule Recalled for Undisclosed Drug Contaminants

    The FDA is recalling maXXzen Platinum 12000 capsules distributed nationwide because the product was marketed without an approved application and contains undisclosed pharmaceutical ingredients (Sildenafil and Tadalafil).

    Product
    maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), Distributed by: Maxx Inc, Los Angeles, CA 90028
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-06-30

    PremierZEN Gold 7000 Capsule Recalled for Undisclosed Drug Contamination

    PremierZEN Gold 7000 capsules are recalled nationwide because the product contains undisclosed pharmaceutical ingredients Sildenafil and Tadalafil and was marketed without FDA approval.

    Product
    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
    Category
    Distribution
    0 states