FDA-Drug2023-12-27Class I

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

Noah's Wholesale LLC
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.

Sold states
Florida, Bahamas, Turks & Caicos Islands
Affected count
173 capsules
Manufactured in
4720 Nw 165th St, N/A, Miami Lakes, FL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0158-2024

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