Drug product
Euphoric Premium Male Performance Enhancer capsules, packaged in a)1-count blister cards, UPC 6 96859 28646 9, b) 3-count bottle, UPC 6 96859 28647 6 and c) 12-count bottle, UPC 6 96859 28648 3.
D-0288-2019
Product summary
- Event
- Event 79842
- Status
- Terminated
- Classification
- Class I
- Quantity
- a) 106,329 cards; b) 109,725 bottles; c) 28,644 bottles
- Official record key
drug-enforcement:D-0288-2019
Official wording
Reason: Marketed Without An Approved NDA/ANDA: product contains undeclared sildenafil, tadalafil, and oxytetracycline, FDA approved drug products making Euphoric an unapproved drug.
Code information: All lots
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Marketed Without An Approved NDA/ANDA: product contains undeclared sildenafil, tadalafil, and oxytetracycline, FDA approved drug products making Euphoric an unapproved drug.