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Recall Observatory FDA recall evidence

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

April 26, 2023

Class I

Product summary

Firm
Gadget Island, Inc
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

    reason.no_named_rule · v1.0.0

    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.