Noah's Wholesale LLC recalls THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distributed by Steele Production…

Recall date

October 16, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0158-2024

FDA classification

Class I

Brand / firm

Noah's Wholesale LLC

Sold / distributed

Florida, Bahamas, Turks & Caicos Islands

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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