APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Dist...
FDA Recall #D-0667-2016 — Class I — December 23, 2015
Product Description
APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7.
Reason for Recall
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.
Recalling Firm
Nuway Distributors, LLC — Orlando, FL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
100,000 blister cards
Distribution
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.
Code Information
All lots
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated