FDA Recalls Rhino 69 Extreme 50000 for Undeclared Tadalafil
The FDA is recalling Rhino 69 Extreme 50000 capsules because they contain undeclared tadalafil, an unapproved drug with unestablished safety and efficacy.
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
The U.S. Food and Drug Administration (FDA) is recalling Rhino 69 Extreme 50000, a product packaged in 1 capsule per blister pack and distributed by AMA Wholesale Inc. in Chino Hills, California. The product is identified by UPC Code 718122071128.
The recall was initiated because FDA analysis found the product contains undeclared tadalafil. The presence of tadalafil makes Rhino Extreme 50000 an unapproved drug for which safety and efficacy have not been established. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The recall is classified as Class I by the FDA. Consumers who have purchased this product should stop using it and follow instructions from the recalling firm or the FDA regarding disposal or return.
The recalled product
- Product
- Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by AMA Wholesale Inc. Chino Hills, CA, 91709-2618, UPC Code: 718122071128
- Manufacturer
- AMA Wholesale
- Category
- Drug — Unapproved 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.
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