The Recall Desk
CriticalFDA (Drugs)·D-0103-2018·Announced 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.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Gadget Island, Inc. is recalling 925 1-capsule packets of Rhino 7 Platinum 5000. The product is distributed by Fifty Shades in Bayside, NY, and was sold nationwide in the USA. The recall covers all lots of the product.

The FDA is recalling this product because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the capsules contain undeclared active pharmaceutical ingredients: sildenafil, desmethyl carbodenafil, and tadalafil.

Consumers who have purchased this product should stop using it and contact the distributor or manufacturer for further instructions.

The recalled product

Product
RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packets, distributed by Fifty Shades Bayside, NY 11361, UPC 617135861224
Manufacturer
Gadget Island, Inc

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Gadget Island, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →