Drug Enforcement D-0586-2024

Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.

Status

Ongoing

Classification

Class I

Report Date

July 10, 2024

Termination Date

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Product Information

Product description
To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026
Product quantity
2500 boxes
Reason for recall
Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Recall initiation reason
—
Initial firm notification
Press Release
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Integrity Products
Address
5613 Park Road Suite 2, N/A

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

Codes & Dates

Recall number
D-0586-2024
Event ID
94366
Recall initiation date
February 1, 2024
Center classification date
July 3, 2024
Code info
Lot HGW221116 (Batch 022123-1), Exp 5/31/2025
More code info
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