Published by What's the Problem?
According to the U.S. Food & Drug Administration (FDA) [1], this recall affects all lots of the following products:
- PremierZEN Extreme 3000
- PremierZEN Black 5000
- Triple SupremeZEN Plus 3500
FDA testing revealed in the recalled supplements the presence of undeclared tadalafil, an ingredient known as a phosphodiesterase (PDE-5) inhibitor contained in products used for the treatment of male erectile dysfunction.
"Consumers with underlying medical issues who take PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 with undeclared tadalafil may experience serious health risks," FDA said. "For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening."
The recalled supplements are packaged in cardboard blisters containing one pill per card and were distributed via Internet sales nationwide in the U.S.
If you purchased any male enhancement pills that are affected by this recall, you should either throw them away or return them to the point of purchase for a refund.
Anyone concerned about a potential adverse reaction to PremierZEN supplements should call their healthcare provider immediately.
This recall began on April 6, 2021.
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Cardiovascular Effects of Tadalafil: Study
A study published in The American Journal of Cardiology [2.] in November 2003 sought to examine the effects of tadalafil on the cardiovascular system.
For the study, the researchers conducted safety assessments on a database of approximately 4,000 subjects who received tadalafil in 60 clinical pharmacology, phase 2, phase 3, and open-label studies.
They found that in healthy subjects, tadalafil caused small changes to the blood pressure which were not believed to be clinically relevant. Daily administration of tadalafil 20 mg for 26 weeks in healthy males with mild erectile dysfunction (ED) resulted in blood pressure changes similar to those in the placebo group. In patients with coronary artery disease (CAD), tadalafil administration before nitrate administration resulted in small decreases in blood pressure.
The authors concluded that tadalafil can be safely used by healthy subjects and by patients with cardiovascular diseases.
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Do I Have a PremierZEN Lawsuit?
The Pharmaceutical Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in PremierZEN Lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
If you or a loved one was injured by a recalled dietary supplement, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.
To contact us for a free review of your potential case, please fill out the form below or call us toll free 24 hrs/day by dialing: 