Shoreside Enterprises Inc., is recalling two dietary supplements promoted for male sexual enhancement after an analysis conducted by the Food and Drug Administration (FDA) revealed the products contained undeclared pharmaceutical drugs. The affected supplements – 7K and Poseidon 4500/Extreme 1000 mg – contain sildenafil and/or tadalafil, the active ingredients in the prescription erectile dysfunction drugs Viagra and Cialis, respectively.
Not only does the presence of these drugs in the dietary supplements render them unapproved drugs for which the safety and efficacy cannot be established, they also pose health risks to some people.
Sildenafil and tadalfil may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may cause a significant drop in blood pressure that can be life threatening. Shoreside Enterprises Inc. has not received any reports of any adverse events related to this recall, to date.
These tainted male enhancement supplements can be identified by their blue color, and lot number on their individual packaging – 7K (Lot #RO) and Poseidon 4500/Extreme 1000 mg (Lot #20117BL). The supplements are packaged in 1 capsule blister packs and were distributed from Feb. 2, 2017, to Dec. 19, 2017, to retail stores in Illinois, Ohio, North Carolina, Massachusetts and Florida.
Any adverse events related to use of 7K or Poseidon 4500/Extreme 1000 mg, should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice