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Products found to contain undeclared medicines

 
The United States: Marmex Corp issues voluntary nationwide recall of Blue Pearl All Natural Male Enhancement Supplement, due to undeclared sildenafil
 
The United States Food and Drug Administration (FDA) announces that Marmex Corp of Orange, CA, is voluntarily recalling all lots of Blue Pearl All Natural Male Enhancement Supplement, 500mg to the consumer level. FDA analysis has found the products to contain sildenafil. Blue Pearl All Natural Male Enhancement Supplement capsules were marketed as a dietary supplement for male enhancement.

The presence of the undeclared active ingredients renders them unapproved drugs for which safety and efficacy have not been established.

Use of products with undeclared sildenafil may pose a threat to consumers because the active ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and might be the most likely to get affected. To date, Marmex Corp has not received any reports of adverse events related to this recall.

Consumers who purchased the product should stop consuming it and return it to place of purchase. 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.

Please refer to the following website in FDA for details: http://www.fda.gov/Safety/Recalls/ucm588969.htm

In Hong Kong, the above product is not a registered pharmaceutical product.



Ends/Thursday, December 14, 2017
Issued at HKT 13:00
 
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