Drug product

Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; Health Fixer, Tempe, AZ 85288, UPC B0CMQ4FTHG.

D-0463-2025

April 14, 2025

Class I

Product summary

Firm: SAINI TRADE INC
Event: Event 96735
Status: Ongoing
Classification: Class I
Quantity: 3000 boxes
Official record key: drug-enforcement:D-0463-2025

Official wording

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

Code information: All Lots Lot #: KT-1ST-43-01-10-2025, Exp. 01/10/2027

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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