← FDA ENFORCEMENT
D-0158-2024Class I

Noah's Wholesale LLC

Recalling firm
Noah's Wholesale LLC
Product type
Drug
Status
Ongoing
Report date
2023-12-27
Distribution
Florida, Bahamas, Turks & Caicos Islands
Firm state
FL
Product quantity
173 capsules
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
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.

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

Code / lot info

Lot# 03032021 Exp: 12/31/2027

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.