Pro Power Max, Evil Root and 72HP By Hardmenstore.com: Recall - Undeclared Ingredient
AUDIENCE: Consumer, Health Professional
ISSUE: Upon request of the FDA, Hardmenstore.com is voluntarily recalling 1000 lots of 72HP, Evil Root and Pro Power Max at the consumer level. According to representatives of the FDA, 72HP, Evil Root and Pro Power Max have reportedly been found to contain amounts of the PDE-5 Inhibitor, sildenafil, which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED) and sildenafil is not listed on the product labels. 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. Additionally, the product may cause side effects,such as headaches and flushing.
BACKGROUND: These products are intended to be used as a dietary supplement and sexual supplement. 72HP is packaged in a single blister pack containing 1 dose. Evil Root is packaged in box containing a bottle of 6 pills. Pro Power Max is packaged in a single blister pack containing 1 dose. All lots of 72HP, Evil Root and Pro Power Max are included in this recall. 72HP can be identified by the yellow packaging with a black horse insignia. Evil Root can be identified by its orange box with blue Chinese characters. Pro Power Max can be identified by the black and red packaging with flames on the bottom of the packaging. These sealed and packaged products were delivered to Hardmenstore.com as having contained only legitimate and lawful ingredients.
RECOMMENDATION: Consumers and retailers that have the 72HP, Evil Root or Pro Power Max supplements should stop using this product immediately, and contact a doctor if any of the side effects have been felt. Consumers with questions regarding this voluntary recall can email email@example.com 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
[08/27/2013 - Firm Press Release - Hardmenstore.com]