APEXXX tablets recalled for containing unapproved sildenafil
Nuway Distributors is recalling APEXXX tablets because they contain sildenafil, an unapproved drug for erectile dysfunction.
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
Nuway Distributors, LLC is recalling APEXXX tablets, 300 mg, packaged in 1-count blister cards. The product was marketed as a dietary supplement but was found to be tainted with sildenafil, an FDA-approved drug for the treatment of male erectile dysfunction. Because the product contains an unapproved drug, it is considered an unapproved drug rather than a dietary supplement.
The recall involves 100,000 blister cards. All lots are affected. The product was sold exclusively to Ace Distributors, LLC in Orlando, FL, a retail store that sells directly to owners of gas stations, convenience stores, and smoke shops, where it can be further distributed nationwide.
Consumers who have purchased APEXXX tablets should stop using the product and return it to the place of purchase for a refund or contact Nuway Distributors, LLC for further instructions.
The recalled product
- Product
- APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7.
- Manufacturer
- Nuway Distributors, LLC
- Category
- Drug — Unapproved Drug
- Affected units
- 100,000
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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