Hi-Tech Pharmaceuticals Recalls Sexual Performance Supplement

The Food and Drug Administration (FDA) has ordered Hi Tech Pharmaceuticals to recall their sexual performance Supplement Stamina-Rx after it was discovered to contain an undeclared ingredient, benzamidenafil. The ingredient is in the same therapeutic class of active pharmaceutical ingredients that include the PDE5 inhibitors sildenafil, tadalafil, and vardenafil, that are FDA-approved for the treatment of erectile dysfunction (ED).

Benzamidenafil is not FDA-approved, and poses a threat to consumers because benzamidenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be most susceptible to adverse effects from this product.

Since the recall is due to an undeclared ingredient and Hi-Tech Pharmaceuticals is under a Consent Decree of Permanent Injunction with FDA since September 23, 2003, FDA has ordered a recall of all lots to the consumer level. Stamina-Rx is sold predominantly in health food and drug stores nationwide. The product is sold in 10, 30, and 40-tablet bottles and in 2 and 6-tablet blister packs.

Customers who have this product in their possession should stop using it immediately. Any adverse events that may be related to the use of this product should be reported to Hi-Tech Pharmaceuticals, Inc., Norcross, GA 30071 at toll-free 1-888-855-7919 from 9:00 AM - 5:00 PM EST.

The public is encouraged to submit a report of any serious adverse events that occur with the use of Stamina-Rx to FDA’s MedWatch Adverse Event Reporting program online at [www.fda.gov/MedWatch/report.htm] or by phone [1-800-FDA-1088].

CEO of Hi-Tech Pharmaceuticals sentenced to 4 years for selling Knock-off Drugs

Jared Wheat, the CEO and founder of Hi-Tech Pharmaceuticals was charged $50,000 and sentenced to 50 months in prison for illegally selling prescription drugs online. He distributed fake versions of a variety of medications which included Xanax, Valium, Ambien, Vioxx, Zoloft, Viagra, and Cialis, which he ultimately sold over the Internet without requiring prescriptions.

Hi-Tech Parmaceuticals is located in Georgia and is known for their herbal supplements which are distributed to a variety of American retailers and convenience stores nationwide. Hi-Tech’s most popular products include Stamina-Rx, which it describes as a "maximum sexual stimulant," Lipodrene, "for advanced appetite control and metabolic stimulation," and Metanabol, a "revolutionary catalyst for increasing lean mass and strength.

By accepting a plea bargain, a variety of other charges against him were dropped. These included such charges as racketeering, blackmail and murder conspiracies, and for spiking supplements with ephedrine alkaloids. The U.S. Food and Drug Administration (FDA) banned ephedrine alkaloid use in 2004 after finding that it has potential for dangerous effects on the heart.

Also as part of the plea, said MSNBC, the defendants admitted to operating a manufacturing facility—described as filthy—in Belize in which they produced generic versions of a variety of medications such as Xanax, Valium, Ambien, Vioxx, Zoloft, Viagra, and Cialis, which they ultimately sold over the Internet without requiring prescriptions.

Apparently, reported MSNBC, Wheat conspired to murder an FDA agent and to blackmail a former assistant U.S. attorney general. And, while the allegations were made based on information provided by confidential informants, the charge was dropped in plea bargaining talks.

If the leadership of a national known manufacturer who distributes nationwide could instigate distribution of fake products, how can the public be protected?

It is for this reason that pedigree by itself cannot protect consumers– What needs authenticated is not just WHO it was received from but also WHAT was received! – For this reason, we recommend authentication of the product itself. To find out more on how authentication can protect your supply from adulteration – please visit www.xstreamsystems.net.