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Recall Observatory FDA recall evidence

Drug product

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

D-0586-2024

February 01, 2024

Class I

Product summary

Firm
Integrity Products
Event
Event 94366
Status
Ongoing
Classification
Class I
Quantity
2500 boxes
Official record key
drug-enforcement:D-0586-2024

Official wording

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

Code information: Lot HGW221116 (Batch 022123-1), Exp 5/31/2025

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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