Recall Issued by Hi-Tech Pharmaceuticals For Undeclared Ingredients in Stamina-Rx
Yesterday on June 15, 2009 Hi-Tech Pharmaceuticals recalled its weight loss supplement Stamina-Rx. Stamina-Rx contains benzamidenafil, an undeclared and not FDA-approved ingredient.
Hi-Tech Pharmaceuticals, Inc. of Norcross, GA manufacturers Stamina-Rx.
On May 1, 2009, the FDA notified Hi-Tech that its lab analysis of Lot 08141578, Exp. 9/10 of Stamina-Rx contains − benzamidenafil − a Phosphodiesterase Type 5 (PDE5) inhibitor. PDE5 inhibitors, like FDA-approved sildenafil, tadalafil, and vardenafil treat erectile dysfunction (ED).
Benzamidenafil is not FDA-approved, and poses a threat to consumers. Benzamidenafil can interact with nitrates found in some prescription drugs (such as nitroglycerin) and can 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.
In addition to the one lot described above, Hi-Tech is recalling all other lots of Stamina-Rx because it is an unapproved new drug and misbranded new drug in violation of the Federal Food, Drug and Cosmetic Act (the Act). Stamina-Rx is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling posted on certain web-based and print media.
Hi-Tech has been under a Consent Decree of Permanent Injunction with the FDA since September 23, 2003. In accordance with the Decree, the FDA determined that additional corrective actions were necessary for Hi-Tech to achieve compliance with the Act and the Decree and therefore, on May 1, 2009 the FDA ordered Hi-Tech to recall all lots of Stamina-Rx to the consumer level.
Customers who have this product in their possession should stop using it immediately. For more information regarding the recall contact: Hi-Tech Pharmaceuticals, Inc., Norcross, GA 30071 at toll-free 1-888-855-7919 from 9:00 AM – 5:00 PM EST.
Please report any adverse events associated with Stamina-Rx to the FDA’s MedWatch program.
The FDA can be contacted via:
Online at www.fda.gov/medwatch/report.htm
Phone at 1-800-FDA-1088
Fax at 1-800-FDA-0178, using the MedWatch Form 3500
(available at www.fda.gov/medwatch/ getforms.htm)
Mail, using the postage-paid MedWatch Form 3500 (see above), to MedWatch, 5600
For more information please see: http://www.fda.gov/Safety/Recalls/ucm167139.htm