Aphrodisiac Platinum 40000 Recalled for Unapproved Sildenafil Contamination
Select Distributions LLC is recalling Aphrodisiac Platinum 40000 because FDA analysis found the product is tainted with sildenafil and was marketed without an approved NDA/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 mandates a severity score of 5 according to the rubric.
Plain-English summary
Select Distributions LLC is recalling 60 boxes of Aphrodisiac Platinum 40000, Proprietary Raw Material 6000 mg. The product is distributed in blister cards with 24 cards per box and carries the UPC code 644118128135. 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, FDA analysis determined that the product is tainted with sildenafil. The product was distributed in Michigan and Ohio.
Consumers who have purchased this product should stop using it immediately. They should contact the recalling firm, Select Distributions LLC, for information on how to return the product or obtain a refund.
The recalled product
- Product
- Aphrodisiac Platinum 40000, Proprietary Raw Material 6000 mg, 1 count blister card, 24 cards per box, Distributed by: APhrodisiac. UPC Code 644118128135
- Manufacturer
- SELECT DISTRIBUTIONS LLC
- Category
- Drug — Unapproved Supplement
- Affected units
- 60
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
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