USDA And Fedwatch Recall Alerts

TOPIC: Hard Steel Capsules and Gold Hard Steel Plus Liquid by Supercore Products Group: Recall – Due to the Presence of Sildenafil and Acetaminophen

AUDIENCE: Consumer, Health Professional, Pharmacy

ISSUE: Supercore Products Group is recalling Hard Steel Capsules and Gold Hard Steel Plus Liquid because FDA analysis found these products to be tainted with sildenafil and acetaminophen. 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 these products renders them 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, those who use nitrates for cardiac conditions are most at risk.

Acetaminophen is a medicine used to reduced pain and fever that is found in many prescriptions, and over-the-counter (OTC) drug products. Use of the products poses a serious threat to consumers because it may result in unintentional acetaminophen overdose, especially if it is used in combination with other acetaminophen-containing products. Acetaminophen overdose can cause liver damage (hepatoxicity), ranging in severity from abnormalities in liver function to acute liver failure, and even death. Victims of unintentional acetaminophen overdose may not seek prompt medical attention because the symptoms of liver damage can take several days to emerge, even in severe cases. Acetaminophen may also cause serious skin reactions. Symptoms may include skin reddening, rash, and blisters.

To date, Supercore Products Group has not received any reports of adverse events related to this recall.

For more information about this recall, click on the red button “Read Recall“ below.

BACKGROUND: The recalled products are used for male enhancement sold and https://hardsteelusa.com.

RECOMMENDATIONS: 

• 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.

• Consumers, distributors, and retailers that have recalled Hard Steel Capsules, and/or Gold Hard Steel Plus Liquid should immediately stop use of the products and return it to place of purchase or discard.

• Consumers with questions regarding this recall can contact Supercore Products Group at 800-573-5933 or e-mail: customersupport@hardsteelusa.com.

Consumers and health professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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