D-0158-2024 Class I Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- December 27, 2023
- Initiation Date
- October 16, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 173 capsules
Product Description
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
Reason for Recall
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.
Distribution Pattern
Florida, Bahamas, Turks & Caicos Islands
Code Information
Lot# 03032021 Exp: 12/31/2027