Drug Enforcement D-0463-2025

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
Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; Health Fixer, Tempe, AZ 85288, UPC B0CMQ4FTHG.
Product quantity
3000 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-0463-2025
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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