Drug product
Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.
D-0281-2025
Product summary
- Event
- Event 96328
- Status
- Ongoing
- Classification
- Class I
- Quantity
- a) 300 individually wrapped capsules b) 20 bottles
- Official record key
drug-enforcement:D-0281-2025
Official wording
Reason: Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
Code information: All lots
Distribution pattern: Nationwide in the U.S.A
Derived failure modes
-
Unknown
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.