AUDIENCE: Consumer, Health Professional
ISSUE: Haute Health, LLC is voluntarily recalling all lots of Virilis Pro, PHUK and Prolifta at the retail and consumer level. Virilis Pro, PHUK and Prolifta have been found to contain amounts of the PDE-5 Inhibitor sildenafil, which is an active ingredient in an FDA-approved drug for erectile dysfunction (ED). Sildenafil has 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.
BACKGROUND: Virilis Pro, PHUK and Prolifta are labeled and intended to be used as dietary supplements for sexual enhancement. Virilis Pro is packaged in a 1 and 2 capsule blister packs and 10 capsule bottles. PHUK is packaged in 1 and 2 capsule blister packs and 4, 12, 24 capsule bottles. Prolifta is packaged in 1 and 2 capsule blister packs and 4, 12, and 24 capsule bottles. All three products are distributed nationwide to wholesale and retail customers and via the internet.
RECOMMENDATION: 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 voluntary recall can contact Michael Carney via email at firstname.lastname@example.org or by phone at 856-404-9474 from Monday to Friday, 11am to 5pm, 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
[09/24/2013 - Firm Press Release]