[Posted 07/24/2017]
AUDIENCE: Consumer
ISSUE: Ultra Shop Supplement is voluntarily recalling Super Panther 7K capsules, (1 count blister card Lot#: RO846356 and 6 count bottle Lot RO246852 within expiry), distributed by SX Power Co., Brooklyn, NY, to the consumer level. FDA analysis found samples of Super Panther 7K to be tainted with undeclared sildenafil and tadalafil, active ingredients in two FDA-approved prescription drug products, also known as phosphodiesterate 5-inhibitors (PDE-5), used to treat erectile dysfunction (ED). The presence of sildenafil and tadalafil in Super Panther 7K renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
Consumers who take this product for erectile dysfunction could have underlying cardiovascular disease. Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; concomitant use of nitrates and PDE-5 can lead to fatal cardiovascular collapse.
BACKGROUND: Super Panther 7K was sold to consumers nationwide in the USA via their retail website.
RECOMMENDATION: Consumers that purchased these products from Ultra Shop directly should stop using them immediately and can contact Ultra Shop at 888-246-9664 Monday-Friday between the hours of (9:00 am to 5:00 pm Eastern time) and request to return the recalled products. 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.
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
- 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
[07/21/2017 - Press Release - Ultra Shop Supplement]
