APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7.
Reported: February 24, 2016 Initiated: December 23, 2015 #D-0667-2016
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.
Details
- Recalling Firm
- Nuway Distributors, LLC
- Units Affected
- 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.
- Location
- Orlando, FL
Frequently Asked Questions
What product was recalled? ▼
APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7.. Recalled by Nuway Distributors, LLC. Units affected: 100,000 blister cards.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 24, 2016. Severity: Critical. Recall number: D-0667-2016.
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