FDA recall D-0667-2016

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.

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.

Key facts

Status

Ongoing

Initiation date

2015-12-23

Report date

2016-02-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Orlando, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0667-2016