Drug Enforcement D-0281-2025

Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.

Status

Ongoing

Classification

Class I

Report Date

March 26, 2025

Termination Date

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Product Information

Product description
Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.
Product quantity
a) 300 individually wrapped capsules b) 20 bottles
Reason for recall
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Nationwide in the U.S.A

Location & Firm

Recalling firm
One Source Nutrition, Inc,
Address
19863 Interstate 30 S, N/A

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

Codes & Dates

Recall number
D-0281-2025
Event ID
96328
Recall initiation date
February 20, 2025
Center classification date
March 17, 2025
Code info
All lots
More code info
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