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THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distribute...

FDA Recall #D-0158-2024 — Class I — October 16, 2023

Recall #D-0158-2024 Date: October 16, 2023 Classification: Class I Status: Ongoing

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.

Recalling Firm

Noah's Wholesale LLC — Miami Lakes, FL

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

173 capsules

Distribution

Florida, Bahamas, Turks & Caicos Islands

Code Information

Lot# 03032021 Exp: 12/31/2027

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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