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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- Category
- Drug — Supplement
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.
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