FDA-Drug2016-02-24Class I
APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7.
Nuway Distributors, LLC
Hazard
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug.
Sold states
All product is sold to Ace Distributors, LLC in Orlando, FL, a retail store, who sells directly to owners of gas stations, convenience stores, and smoke shops where it can be further distributed nationwide.
Affected count
100,000 blister cards
Manufactured in
9020 Pecky Cypress Way, Orlando, FL, United States
Products
APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0667-2016Don't want to check this manually?
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