FDA recall D-0586-2024

Integrity Products · Class I · 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

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2024-02-01
Report date
2024-07-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
High Ridge, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0586-2024