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.
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.
Recall initiated: 20151223
Status: Ongoing
Classification: Class I
Recall type: Voluntary: Firm initiated