Drug Enforcement D-0571-2023

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.

Status

Ongoing

Classification

Class I

Report Date

May 10, 2023

Termination Date

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Product Information

Product description
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.
Product quantity
628 blister cards
Reason for recall
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.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA.

Location & Firm

Recalling firm
Gadget Island, Inc
Address
1275 Halyard Dr Ste 175

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0571-2023
Event ID
92203
Recall initiation date
April 26, 2023
Center classification date
May 11, 2023
Code info
No lot number, Exp: 06/2026
More code info
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