November 21, 2013

Tendex Recalls P-Boost, NatuRECT Due to Undeclared Active Ingredients

The Missouri Department of Health and Senior Services received information regarding a recall of Lot# F51Q of P-Boost and Lot # F51Q of NatuRECT. FDA laboratory analysis on Lot# F51Q of P-Boost, which the firm also labels as NatuRECT, has determined that this product contains undeclared tadalafil. Tadalafil is an active ingredient of FDA-approved drugs used to treat erectile dysfunction (ED), making these products unapproved drugs.

The undeclared active ingredient poses a threat to consumers because tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to unsafe levels. Consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

These products are labeled and intended to be used as dietary supplements for sexual enhancement. They are packaged in 1 capsule blister packs and 5, 10, 20, 40 capsule bottles. Both products are distributed nationwide to wholesale and retail customers and via the internet.

The full recall can be found at www.fda.gov/Safety/Recalls/ucm375815.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.


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