THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distributed by Steele Productions
Summary
The FDA issued a Class I for THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister by Noah's Wholesale LLC. Reason: 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.
Details
Source
Drug Recall
External ID
D-0158-2024
Action Date
2023-12-27
Status
Ongoing
Category
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
Lot/Code Info: Lot# 03032021 Exp: 12/31/2027
Quantity Affected: 173 capsules
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
Florida, Bahamas, Turks & Caicos Islands
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-16
Company
Miami Lakes, FL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 25 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Noah's Wholesale LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Noah's Wholesale LLC have FDA actions?
This is the only FDA action we have on record for Noah's Wholesale LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0158-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for drugRelated Actions
Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jef
ProRx LLC · 2025-11-05
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU IN
Perrigo Company PLC · 2022-03-02
Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 8826
Little Moon Essentials LLC · 2024-07-10
Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection
CARDINAL HEALTHCARE · 2024-01-03
HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 6
Sentara Infusion Services · 2023-02-22