FDAFDA · Food and drugs·Recall number D-0158-2024
THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distributed by Steele Productions: Hallandale, FL 33008 UPC 6 61799 95052 7
Published December 27, 2023 · Recall initiated: October 16, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Noah's Wholesale LLC
- Distributor
- Florida, Bahamas, Turks & Caicos Islands
- Lot
- Lot# 03032021 Exp: 12/31/2027
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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