Drug Enforcement D-0465-2025

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

Status

Ongoing

Classification

Class I

Report Date

June 18, 2025

Termination Date

Product Information

Product description
ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J.
Product quantity
300 boxes
Reason for recall
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, 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-0465-2025
Event ID
96735
Recall initiation date
April 14, 2025
Center classification date
June 11, 2025
Code info
All lots Lot #: KT-1ST-43-01-07/2024, Exp. 10/15/2026
More code info