Nasutra, LLC Issues a Voluntary Nationwide Recall of Nasutra, a Product Marketed as a Dietary Supplement To Support Male Sexual Performance, Due to Unlisted, Potentially Hazardous Ingredient

The Food and Drug Administration (FDA) released the following information:

Contact:
Nasutra, LLC at info@nastura.com

Nasutra, LLC announced that it is conducting a voluntary nationwide recall of all the Company's dietary supplement product that is sold under the brand name Nasutra.  Finished product from several lots of Nasutra was tested and preliminarily found to contain an analogue of an ingredient in an FDA-approved drug.  Analytical tests conducted by the Food and Drug Administration (FDA) of Nasutra samples from two lots concluded that the products contained acetildenafil.  Acetildenafil is an analogue of sildenafil.  Sildenafil is the active pharmaceutical ingredient in Viagra, an FDA-approved drug that is used to treat erectile dysfunction (ED).  Acetildenafil is close in structure to sildenafil and is expected to possess a similar pharmacological and adverse event profile.  This poses a threat to consumers because acetildenafil 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.  ED is a common problem in men with these conditions, and they may seek products to enhance sexual performance.  Additionally, acetildenafil, like sildenafil, may cause side effects, such as headaches and flushing.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. 

The Company is advising consumers to return any unused Nasutra, for a refund of the full purchase price, to the retail location from which it was purchased or to the Company directly if it was purchased from the Company as a part of its Direct Response Program.  Consumers can call 1-800-568-3374 to receive instructions for returning the product.  Additional information is provided on the Company's website at www.nasutra.com/recall.

Any adverse events that may be associated with the use of this product and/or quality problems should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or on the MedWatch website at www.fda.gov/medwatch.

The Company is taking this voluntary action because it is committed to providing accurate information on the label of its products and because it is always concerned with the health of persons who have consumed this product.  The Company is reviewing the procedures and policies of all firms involved with the manufacture of the product to ensure that there will be no future issues with regard to Nasutra's composition and labeling. The Company is working closely with the FDA in the recall process and is committed to the quality and integrity of its products. It sincerely regrets any inconvenience to consumers and its other customers and the incomplete Nasutra labeling information.

Type of Recall:
Class I - This is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.