TOPIC: The Rock by Noah’s Wholesale: Recall - Due to Presence of Undeclared Sildenafil
AUDIENCE: Consumer, Health Professional, Pharmacy
ISSUE: Noah’s Wholesale is recalling one lot of the rock# 03032021, Exp:12/2027,1200 mg/capsule because 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.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: This tainted product, The Rock, is marketed as a dietary supplement for male sexual enhancement.
RECOMMENDATIONS:
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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.
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Consumers that have the recalled product should stop using the product and return it to the place of purchase or discard the product immediately.
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Distributors and retailers should stop selling the product and contact Noah’s wholesale for refund process.
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Consumers with questions regarding this recall can contact the company.
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