Products found to contain undeclared medicines
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| The United States: Reesna Inc., issues a voluntary nationwide recall of Fuel Up Plus and Fuel Up High Octane due to the presence of undeclared hydroxythiohomosildenafil |
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Reesna Inc., Canoga Park, CA, is voluntarily recalling all lots of Fuel Up Plus and Fuel Up High Octane particularly distributed in August 2015 due to containing undeclared hydroxythiohomosildenafil, an analogue of sildenafil.
Sildenafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making Fuel Up an unapproved drug. The problem was found after FDA sampled the product and the results were positive for undeclared hydroxythiohomosildenafil. Hydroxythiohomosildenafil is close in structure to sildenafil and is expected to possess a similar pharmacological and adverse event profile. This poses a threat to consumers because sildenafil 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. No illnesses or injuries have been reported to the company to date in connection with this product.
Fuel Up is marketed as a dietary supplement sexual enhancer for men. The product was sold to distributors and retail stores nationwide and via internet sales.
Consumers should contact their physician if they have experienced any problems that may be related to taking this product.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm476978.htm
In Hong Kong, the above products are not registered pharmaceutical products. Related news was issued by the US FDA, and was posted on the Drug Office website on 26 October 2015.
Ends/ Monday, December 14, 2015
Issued at HKT 13:00
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