Rhino 7 Platinum 3000 Recalled for Undeclared Active Ingredients
Tf Supplements is recalling Rhino 7 Platinum 3000 because it contains undeclared desmethyl carbondenafil and dapoxetine and was marketed without an approved NDA or ANDA.
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 per the rubric mandates a score of 5 (Critical) regardless of other factors.
Plain-English summary
Tf Supplements is recalling Rhino 7 Platinum 3000, 1 count Blister Pack, distributed by Rhino 7. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The recall involves 128 blister packs distributed nationwide.
The recall was initiated because the product contains undeclared desmethyl carbondenafil and dapoxetine. These ingredients were not declared on the product labeling. All lots of the product are affected.
Consumers who have purchased Rhino 7 Platinum 3000 should stop using the product and contact the recalling firm for further instructions. The product was made in the USA and has the UPC 700729253748.
The recalled product
- Product
- Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA, UPC 700729253748
- Manufacturer
- Tf Supplements
- Category
- Drug — Dietary Supplement
- Affected units
- 128
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 Tf Supplements 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 · Tf Supplements
See all →- CriticalTf Supplements Recalls Rhino 7 3000 Due to Undeclared Ingredients
FDA (Drugs) · 2016-03-16
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