Unlisted Substances Prompt Supplement Recall from Ultra Shop
To date, Ultra Shop Supplement has not received any reports of adverse events related to this recall
Ultra Shop Supplement has announced that it is recalling a drug due to the presence of undeclared substances.
Recalled product details
The recall applies to the company's Super Panther 7K capsules, distributed by SX Power Co. to the consumer level. Analysis by the U.S. Food and Drug Administration (FDA) 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 these substances renders it an unapproved drug.
The recalled product was sold in one-count blister cards bearing lot number RO846356 and six-count bottles bearing lot number RO246852.
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. Simultaneous use of nitrates and PDE-5 can lead to fatal cardiovascular collapse.
To date, Ultra Shop Supplement has not received any reports of adverse events related to this recall.
Customers interested in a refund, or with general questions about the recall, can contact the company at (888) 246-9664.