Dietary Supplement Libipower Plus Recalled

Haloteco just announced it is conducting a nationwide voluntary recall of its dietary supplement sold under the name <"">Libipower Plus. The recall is being conducted after Haloteco was informed by a U.S. Food and Drug Administration (FDA) representative that lab analysis of Libipower Plus samples found the supplement contained tadalafil, the active ingredient of FDA-approved drugs for Erectile Dysfunction (ED). The product label does not state it contains tadalafil.

We have long been following the trend of ED 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.

In this case, the product may also cause side effects, such as headaches and flushing. Libipower Plus is sold as a one-capsule blister pack through distributors and retail stores in California.

Customers who have recalled Libipower Plus in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. Any adverse events that may be related to the use of this product should be reported to FDA’s MedWatch Program by phone, toll-free, at 1-800-FDA-1088; by fax at 1-800-FDA-0178; or by mail to MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787. Consumers with questions may contact Haloteco Monday through Friday 8:00 am to 5:00 pm at 1-213-820-9523.

Unfortunately, supplement recalls of this type are not unusual. Recently, we wrote that Hi-Tech Pharmaceuticals Inc. recalled Stamina-Rx because the supplement could contain benzamidenafil, also not listed on product packaging; a dangerous omission because benzamidenafil mimics the active ingredient used for (ED) drugs. Earlier this year we wrote that Nature & Health Company issued a nationwide recall of its Libimax product, citing the 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, rendering Libimax an unapproved drug. 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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