D-0667-2016 Class I Ongoing
FDA drug recall D-0667-2016 was initiated by Nuway Distributors, LLC on December 23, 2015 and is designated Class I. 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 dysfunctio… The recall status is ongoing. Affected quantity: 100,000 blister cards.
Recall Details
- Product Type
- Drugs
- Report Date
- February 24, 2016
- Initiation Date
- December 23, 2015
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100,000 blister cards
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.
Distribution Pattern
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.
Code Information
All lots