TOPIC: Thumbs Up 7 Red 70K by Antoto-K: Recall – Due to Presence of Undeclared Sildenafil and Tadalafil
AUDIENCE: Consumer, Health Professional
ISSUE: Antoto-K is recalling all lots of Thumbs Up 7 Red 70K because FDA analysis has found the product to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil in Thumbs Up 7 Red 70K makes them unapproved new drugs for which the safety and efficacy have not been established and therefore subject to recall.
Consumers with underlying medical issues who take Thumbs Up 7 Red 70K with undeclared sildenafil and tadalafil may experience serious health risks. For example, phosphodiesterase (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. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.
To date, Antoto-K has not received any reports of adverse events related to this recall.
For more information about this recall, click on the red button “Read Recall” below.
BACKGROUND: Sildenafil and tadalafil are ingredients known as PDE-5 inhibitors found in FDA approved products for the treatment of male erectile dysfunction.
This tainted product is marketed as a dietary supplement for male sexual enhancement
RECOMMENDATIONS:
- Consumers that have Thumbs Up 7 Red 70K which is being recalled should stop using and destroy them.
- Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
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