Drug product
MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, UPC B0CWKZ6ZP3.
D-0464-2025
Product summary
- Firm
- SAINI TRADE INC
- Event
- Event 96735
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 500 boxes
- Official record key
drug-enforcement:D-0464-2025
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-43-01-04/2026, Exp. 04/25/2026
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.