FDAFDA · Food and drugs·Recall number D-0667-2016
APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7.
Published February 24, 2016 · Recall initiated: December 23, 2015
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Nuway Distributors, LLC
- Distributor
- 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
- All lots
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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