Hi-Tech Pharmaceuticals, Inc., Norcross, GA, has recalled its product sold under the name Stamina-Rx, because the product contains an undeclared ingredient capable of causing a dangerous and life-threatening adverse event in patients taking certain prescription drugs.
Benzamidenafil, a Phosphodiesterase Type 5 (PDE5) inhibitor, was discovered by the FDA during a laboratory analysis of one lot of Stamina-Rx. The lot number found to contain benzamidenafil is Lot 08141578, Exp. 9/10, however, all lots of Stamina-Rx are subject to the recall.
Stamina-Rx is sold nationwide in health food and drug stores in 10, 30, and 40-tablet bottles and in 2 and 6-tablet blister packs.
According to the company press release:
Benzamidenafil 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.
Customers are warned to stop using the product immediately.
Adverse events that occur with the use of Stamina-Rx should be reported to the FDA’s MedWatch Adverse Event Reporting Program as follows:
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online at www.fda.gov/MedWatch/report.htm ,
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by phone (1-800-FDA-1088),
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by returning the postage paid FDA form 3500 (which may be downloaded from www.fda.gov/MedWatch/getforms.htm ) and mailing to MedWatch, 5600 Fishers Lane, Rockville, MD 20853-9787, or
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by fax (1-800-FDA-0178).
For 25 years, the Law Firm of Eric H. Weinberg has helped hundreds of individuals injured by recalled drug products. We are ready to help you. If you believe that you have suffered an injury related to the use of Stamina-Rx, please click Free Legal Case Evaluation, or call us toll free at 1-877-934-6274.
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