Drug Enforcement D-0466-2025

Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.

Status

Ongoing

Classification

Class I

Report Date

June 18, 2025

Termination Date

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Product Information

Product description
ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, UPC B0CYJ7Y5H9.
Product quantity
500 boxes
Reason for recall
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
SAINI TRADE INC
Address
1405 N Scottsdale Rd

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

Codes & Dates

Recall number
D-0466-2025
Event ID
96735
Recall initiation date
April 14, 2025
Center classification date
June 11, 2025
Code info
All lots Lot #: KT-1ST-43-01-10/2025, Exp. 01/10/2027
More code info
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