FDA Recall D-0585-2024

Integrity Products · High Ridge, MO

Class I — life-threatening Ongoing 833 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026

Lot / code: Lot HGW221116 (Batch 020123-1), Exp 5/31/2025

Quantity: 2500 boxes

Reason for recall

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

Recall record

Recall number: D-0585-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide in the USA
Recall initiated: 2024-02-01
Classified by FDA Center: 2024-07-03
FDA published: 2024-07-10
Recalling firm: Integrity Products
Firm location: High Ridge, MO

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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