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The United States: Supercore Products Group, Inc. Issues Voluntary Worldwide Recall of Hard Steel Capsules & Gold Hard Steel Plus Liquid Due to the Presence of Sildenafil and Acetaminophen (Paracetamol) (English only)
 
The United States Food and Drug Administration (FDA) announces that Atlanta, GA, Supercore Products Group is voluntarily recalling of Hard Steel Capsules & Gold Hard Steel Plus Liquid to the consumer level. FDA analysis has found these products to be tainted with sildenafil and acetaminophen (paracetamol). 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.

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.

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

Please refer to the following website in FDA for details: http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/supercore-products-group-inc-issues-voluntary-worldwide-recall-hard-steel-capsules-gold-hard-steel

In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by FDA, and was posted on the Drug Office website on 11 Jul 2024 and 6 Jul 2024 respectively

Ends/ Saturday, Jul 13, 2024
Issued at HKT 13:00
 
Related Information:
The United States: Gold Hard Steel Plus contains hidden drug ingredient (English... 上载于 2024-07-11
The United States: Hard Steel contains hidden drug ingredients, sildenafil and a... 上载于 2024-07-06
 
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