The Recall Desk
CriticalFDA (Drugs)·D-0672-2016·Announced 2016-02-24

Rhino 7 3000 Recalled for Undeclared Active Pharmaceutical Ingredients

Premiere Sales Group is recalling Rhino 7 3000 bottles because they contain undeclared active pharmaceutical ingredients, desmethyl carbondenafil and dapoxetine.

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

Premiere Sales Group is recalling 337 bottles of Rhino 7 3000, a 6-count bottle product distributed by Rhino 7 and made in the USA. The recall covers all lots of the product.

The FDA is recalling these products because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the products contain undeclared active pharmaceutical ingredients: desmethyl carbondenafil and dapoxetine.

The recall is distributed nationwide. Consumers who have purchased Rhino 7 3000 should stop using the product and contact the recalling firm for further instructions.

The recalled product

Product
Rhino 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA
Affected units
337

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 →

Same manufacturer · Premiere Sales Group

See all →