RezzRX: Recall - Undeclared Drug Ingredients
AUDIENCE: Consumer, Health Professional
ISSUE: Fossil Fuel Products, LLC, is recalling lots QL110714A102 and QL110408B046 of “RezzRX.” Laboratory analysis conducted by the FDA determined the RezzRX lot QL110714A102 contains undeclared hydroxylthiohomosildenafil and aminotadalafil and RezzRX lot QL110408B046 contains undeclared hydroxylthiohomosildenafil. The products have been found to contain 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.
BACKGROUND: RezzRX is marketed as a natural supplement for sexual enhancement. RezzRX was distributed nationwide through various websites and retail stores in Georgia.
RECOMMENDATION: Consumers, distributors and retailers that have product which is being recalled should stop using and return 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. Consumers with questions regarding this recall can contact Fossil Fuel Products, LLC, by 1-877-773-9979 or firstname.lastname@example.org, Monday-Friday, 9:00 am- 5:00 pm, EST.
Healthcare professionals and patients 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: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[11/18/2013 - Firm Press Release - Fossil Fuel Products, LLC]