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What’s the Problem?
According to the U.S. Food & Drug Administration (FDA) , this recall affects all lots of the following products:
- Shogun-X 15000mg
- Thumbs up 7 Red 70K
- Krazy Night
Routine testing by the FDA found that the above products contain undeclared tadalafil, sildenafil & vardenafil.
“Tadalafil, Sildenafil & Vardenafil are ingredients known as phosphodiesterase (PD-5) inhibitors found in FDA-approved products for the treatment of male erectile dysfunction,” the FDA said. “Consumers with underlying medical issues who take Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night capsules with undeclared Tadalafil Sildenafil & Vardenafil may experience serious health risks. 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 pills were packaged in blister foil sheets in a box containing 10 capsules and distributed nationwide via Internet sales.
If you purchased any supplements 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 the above products should contact their healthcare provider immediately.
This recall began on March 31, 2021.
Related Article: Active Male by Natural Remedy Litigation
Unapproved Pharmaceutical Ingredients Included in Dietary Supplements: JAMA Study
A study published in JAMA Network Open in October 2018 [2.] looked at trends across adulterated dietary supplements associated with a warning released by the FDA from 2007 through 2016.
The researchers found that unapproved pharmaceutical ingredients were identified in 776 dietary supplements, and these products were commonly marketed for sexual enhancement, weight loss, or muscle building. The most common adulterants were sildenafil for sexual enhancement supplements, sibutramine for weight loss supplements, and synthetic steroids or steroid-like ingredients for muscle-building supplements, with 157 products containing more than 1 unapproved ingredient.
“Active pharmaceuticals continue to be identified in dietary supplements, especially those marketed for sexual enhancement or weight loss, even after FDA warnings,” the researchers concluded. “The drug ingredients in these dietary supplements have the potential to cause serious adverse health effects owing to accidental misuse, overuse, or interaction with other medications, underlying health conditions, or other pharmaceuticals within the supplement.”
See all related dietary supplement lawsuits our attorneys covered so far.
Do I Have a Shogun-X Lawsuit?
The Pharmaceutical Litigation Group at Schmidt and Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Shogun-X 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 recalled dietary supplements, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.