Stamina-Rx Recalled for Undisclosed Ingredients, Misleading Information

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Yet another <"">defective supplement

—Stamina Rx—is being recalled for undeclared ingredients that could dangerously interact with other medications. Also, reports Total Recall Info, the recall was implemented due to misleading labeling and promotional information.

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Total Recall Info reported that Hi-Tech Pharmaceuticals Inc. is recalling bottles and packages of Stamina-Rx because the supplement could contain benzamidenafil. Benzamindenafil is not listed on the Stamina-Rx packaging; a dangerous omission because benzamidenafil mimics the active ingredient used for erectile dysfunction (ED) drugs and could interact with nitrates prescribed for diabetes, high blood pressure, high cholesterol, heart disease, or other problems. This interaction could also result in dangerously low blood pressure, added Total Recall Info.

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Incendiary move Stamina-RX has also been recalled because label or promotional materials contain misleading information about how the supplement should be used, said Total Recall Info, which added that the recalled Stamina-Rx supplements were sold nationwide in 10-, 30-, and 40-tablet bottles as well as in two- and six-tablet blister packs.

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Unfortunately, supplement recalls of this type are not unusual. Earlier this year we wrote that Nature & Health Company issued a nationwide recall of its Libimax product, citing the U.S. Food and Drug Administration

(FDA). Libimax was marketed as a dietary supplement but was found to contain an active ingredient in an FDA-approved drug. FDA laboratory analysis of Libimax samples found Libimax to contain tadalafil, an active ingredient of an FDA-approved drug for ED. The finding rendered Libimax an unapproved drug; the FDA said the finding poses a threat to consumers because tadalafil may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels. Tadalafil may also cause headaches and flushing, said the FDA.

We have long been reporting on the issue of erectile dysfunction supplements containing undeclared ingredients. This issue is of particular and serious concern because ED is a common problem in men with diabetes, high blood pressure, high cholesterol, or heart disease. These patients are often advised against taking ED drugs and may look for alternative products because they are marketed as “all natural” or as not containing the active ingredients in approved, prescribed ED drugs. The use of undeclared chemicals poses a threat to these consumers because they may harmfully interact with nitrates found in some prescription drugs, such as nitroglycerin, and may dangerously lower blood pressure. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take such nitrates.

Also, in one of many similar such situations, we reported earlier this year that Bodee LLC, Inc. of Century City, California issued a voluntary, nationwide recall of all of its Zencore Tabs, citing an FDA announcement. An FDA laboratory analysis by the agency found that the Zencore Tabs analyzed contained a potentially harmful, undeclared active ingredient of an FDA-approved drug, also used to treat ED.

In March, the Government Accountability Office (GAO) issued a report urging the FDA to implement improvements on its monitoring and governing of dietary supplements, the LA Times reported previously, noting that, in the United States, vitamins, minerals, and herbs accounted for a $24.7 billion business in 2007.

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