P-Boost, NatuRECT by Tendex: Recall - Undeclared Drug Ingredient

[Posted 11/20/2013]

AUDIENCE: Consumer, Health Professional

ISSUE: Tendex is voluntarily recalling Lot# F51Q of P-Boost and Lot # F51Q of NatuRECT to the consumer level. 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.

BACKGROUND: 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.

RECOMMENDATION: Tendex is notifying its distributors and customers by direct mail or email and is arranging for return of all recalled products. Consumers that have product which is being recalled should stop using and return to place of purchase.

Consumers with questions regarding this recall can contact Tendex by phone (800) 984-0341, from Monday to Friday, 9:00AM-5PM PST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[11/19/2013 - Press Release - Tendex]