VitaliKOR Fast Acting Dietary Supplement Recall [US]

US FDA RecallUS/Silver Spring: Vitality Research Labs recalls some VitaliKOR Fast Acting Dietary Supplements due to undeclared drug hazard, specifically Vardenafil and Tadalafil. FDA:

VitaliKOR Dietary Supplements

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Additional information:
The US Food and Drug Administration (“FDA”) reports the following dietary supplements are subject to this recall: Continue reading

Rock-It Man Male Enhancement Supplement Recall [US]

US FDA RecallUS/Silver Spring: Consumer Concepts recalls some Rock-It Man Male Enhancement Capsules due to undeclared prescription drug analogue. FDA:

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Additional information:1842 - Rock-ItManSupplement
The US Food and Drug Administration (“FDA”) reports Rock-It Man Male Enhancement Capsules sold between October 2012 and April 2013 were tested and found to contain an analogue of an ingredient in an FDA-approved drug. Further tests conducted by the FDA concluded the recalled Supplements contained hydroxythiohomosildenafil.

The chemical Hydroxythiohomosildenafil is an analogue of sildenafil and is close in structure to sildenafil and is consequently, expected to possess a similar pharmacological and adverse event profile. Sildenafil is the active pharmaceutical ingredient in an FDA approved drug that is used to treat Erectile Dysfunction (“ED”) making the recalled Rock-It Man Male Enhancement an unapproved new drug.

According to the FDA, the undeclared active ingredient poses a threat to consumers because hydroxythiohomosildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates as part of their treatment plan under the supervision of a medical doctor. Additionally, hydroxythiohomosildenafil, like sildenafil, may cause side effects, such as headaches and flushing.


Recalls Direct RIN: 2013-1842
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