Class I
Ongoing
APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7.
- Company
- Nuway Distributors, Llc
- Recall Initiated
- December 23, 2015
- Posted
- February 24, 2016
- Recall Number
- D-0667-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 100,000 blister cards
- Firm Location
- Orlando, FL, United States
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.
Lot / Code Info
All lots
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