Rhino 7 Platinum 3000 Recalled for Undeclared Active Ingredients
FDA recalls Rhino 7 Platinum 3000 because it contains undeclared active pharmaceutical ingredients, desmethyl carbondenafil and dapoxetine.
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 minimum severity score of 5 according to the rubric.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Rhino 7 Platinum 3000, 1 count Blister Pack. The product is distributed by Rhino 7 and manufactured by Premiere Sales Group. The recall covers all lots and is distributed nationwide.
The recall was initiated because the product was marketed without an Approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product contains undeclared active pharmaceutical ingredients, specifically desmethyl carbondenafil and dapoxetine.
Consumers who have purchased Rhino 7 Platinum 3000 should stop using the product immediately. The FDA advises consumers to contact their healthcare provider if they have any questions or concerns regarding the use of this product.
The recalled product
- Product
- Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA
- Manufacturer
- Premiere Sales Group
- Category
- Drug — Prescription/OTC Drug
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 2 recalled by Premiere Sales Group 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 2 products in this recall →Related recalls
Same manufacturer · Premiere Sales Group
See all →- CriticalRhino 7 3000 Recalled for Undeclared Active Pharmaceutical Ingredients
FDA (Drugs) · 2016-02-24
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