COMPANY ANNOUNCEMENT
Noah’s Wholesale, LLC Issues Voluntary Nationwide Recall of the Rock Due to Presence of Undeclared Sildenafil
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Read AnnouncementSummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
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Recall Reason DescriptionUndeclared drug, Sildenafil
- Company Name:
- Noah’s Wholesale, LLC
- Brand Name:
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Brand Name(s)Noah’s Wholesale, LLC
- Product Description:
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Product DescriptionDietary Supplement with undeclared Sildenafil
Company Announcement
FOR IMMEDIATE RELEASE – October 18, 2023 – Miami Gardens, Florida, Noah’s Wholesale, LLC is voluntarily recalling one lot of the rock# 03032021,exp:12/2027,1200 mg/capsule, to the consumer level. FDA analysis has found the product to be tainted with Sildenafil. Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) found in FDA-approved products for the treatment of male erectile dysfunction. The presence of sildenafil in this product renders the rock an unapproved drug for which the safety and efficacy has not been established and, therefore, subject to recall.
Risk Statement: Consumption of products with undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk. Noah’s Wholesale has not received any reports of adverse events related to this recall to date.
This tainted product, The Rock, is marketed as a dietary supplement for male sexual enhancement and is packaged as a single pill in a blister pack. It is labeled as ORIGINAL THE ROCK, Male sexual performance, with the following UPC 6 61799 95052 7. Distributed by: Steele Products, Hallandale, FL. The Rock affected lot is lot#03032021,Exp:12/2027. The product can be identified by the red and black lettering on a white-flat small cardboard package with one red capsule seen through a clear blister window. The product was distributed locally through convenience stores and some island jobbers (small wholesale distributors to retail).
Noah’s Wholesale is notifying its distributors and customers by phone, emails and through their sales representative and is arranging for a full refund/credit of all recalled products. Consumers that have the recalled product should stop using the product and return it to the place of purchase or discard the product immediately. Distributors and retailers should stop selling the product and contact Noah’s wholesale LLC for refund process.
Consumers with questions regarding this recall can contact Noah’s wholesale by calling 305-626-8444 or emailing them at : noahswholesale@gmail.com, Monday through Friday 10am to 5pm Est. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.