Drug product
Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by Beyond Health and youth Inc, Seattle, WA 98110, UPC 4 94922 90522 0.
D-0571-2023
Product summary
- Event
- Event 92203
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 628 blister cards
- Official record key
drug-enforcement:D-0571-2023
Official wording
Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Code information: No lot number, Exp: 06/2026
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Unknown
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.