The Recall Desk

FDA (Drugs) recall action 78151

Gadget Island, Inc recalled 4 products on 2017-12-13

The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2017-12-13
Critical
4
Units
—

Why these products were recalled

Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.

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

1–4 of 4

  • CriticalFDA (Drugs)··2017-12-13

    Grande X 5800 Capsules Recalled for Undeclared Prescription Ingredients

    Gadget Island, Inc. is recalling Grande X 5800 capsules because they contain undeclared prescription drugs sildenafil, desmethyl carbodenafil, and tadalafil.

    Product
    grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana Seed 80 mg, Ginko Leaf 60 mg, Saw Palmetto 100 mg, Damiana Leaf 100 mg, Ginseng Root 80 mg, Tribulus Terrestris 90 mg, Tongkat Alo 100 mg, Rhodiola Rosea 60 mg, L-Arginine 90 mg), 1-capsule packets, distri
    Category
    Distribution
    0 states
  • CriticalFDA (Drugs)··2017-12-13

    Gadget Island Recalls Unapproved Rhino 7 Platinum 5000 Capsules

    Gadget Island, Inc. is recalling Rhino 7 Platinum 5000 capsules because they contain undeclared active pharmaceutical ingredients and were marketed without FDA approval.

    Product
    RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packets, distributed by Fifty Shades Bayside, NY 11361, UPC 617135861224
    Category
    Distribution
    0 states
  • CriticalFDA (Drugs)··2017-12-13

    PapaZen 3300 capsules recalled for undeclared prescription ingredients

    Gadget Island, Inc. is recalling PapaZen 3300 capsules because they contain undeclared prescription drugs sildenafil, desmethyl carbodenafil, and tadalafil.

    Product
    PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 718122032587
    Category
    Distribution
    0 states
  • CriticalFDA (Drugs)··2017-12-13

    Gadget Island Recalls FIFTY SHADES 6000 Capsules for Undeclared Ingredients

    Gadget Island, Inc. is recalling FIFTY SHADES 6000 capsules because they contain undeclared active pharmaceutical ingredients sildenafil, desmethyl carbodenafil, and tadalafil.

    Product
    FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading, UPC 4026666146056
    Category
    Distribution
    0 states