FDA MedWatch – Premium OrgaZen 7000 and Ginseng Power 5000 By NS NY Distributor:

TOPIC: Premium OrgaZen 7000 and Ginseng Power 5000 By NS NY Distributor: Recall – Due to Presence of Undeclared Sildenafil and/or Tadalafil

AUDIENCE: Consumer, Health Professional

ISSUE: NS NY Distributor Inc is recalling all lots of Premium Orgazen 7000 and Ginseng Power 5000 capsules because FDA analyses found the products to contain undeclared sildenafil and/or tadalafil. The presence of sildenafil and/or tadalafil in Premium OrgaZen 7000 and Ginseng Power 5000 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 Premium OrgaZen 7000 capsules and Ginseng Power 5000 with undeclared sildenafil and/or 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, NS NY Distributor Inc 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 known as PDE-5 inhibitors found in FDA approved products for the treatment of male erectile dysfunction. These tainted products are marketed as a dietary supplements for male sexual enhancement.

RECOMMENDATIONS: 

• Consumers that have Premium OrgaZen 7000 and Ginseng Power 5000 which are being recalled should stop using and destroy them. 
• Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Health professionals and consumers 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.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.