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Products found to contain undeclared medicines

The United States: Fossil Fuel Products, LLC, Issues Voluntary Nationwide Recall of “RezzRX” Due to Undeclared Active Ingredients Hydroxylthiohomosildenafil and Aminotadalafil
The US Food and Drug Administration (FDA) announced that Fossil Fuel Products, LLC, is voluntarily recalling lots QL110714A102 (20-count bottles) and QL110408B046 (single blister packs) of “RezzRX” to the consumer level. Laboratory analysis conducted by the FDA determined the RezzRX lot QL110714A102 (20-count bottles) contains undeclared hydroxylthiohomosildenafil and aminotadalafil and RezzRX lot QL110408B046 (single blister packs) contains undeclared hydroxylthiohomosildenafil. The products have been found to contain hydroxylthiohomosildenafil and amionotadalafil which are active ingredients of FDA approved drugs used to treat erectile dysfunction (ED), making “RezzRX” an unapproved new drug.

These undeclared active ingredients pose a threat to consumers because use of these products have the potential to interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to unsafe levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, may cause side effects, such as headaches and flushing. Fossil Fuel Products, LLC, has not received any reports of adverse events related to this recall.

The product is marketed as a natural supplement for sexual enhancement. RezzRX was distributed nationwide through various websites and retail stores in Georgia.

Please refer to the following website in FDA for details:

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

Ends/ Wednesday, November 20, 2013
Issued at HKT 14:00