The U.S. Food and Drug Administration (FDA) just announced <"http://www.yourlawyer.com/practice_areas/defective_drugs">two supplement recalls. Young You Corporation of Tarzana, California was recently informed by the FDA that four weight loss dietary supplements it sold and marketed contain an undeclared drug ingredient. Also, Opteron 1 Inc., of Brea, California, which does business as Nature & Health Company, just issued a recall of five of its supplement products.
Young You Corporation
FDA lab analyses of dietary supplements distributed by Young You were found to contain undeclared sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss. The FDA has not approved the following products as drugs; therefore, the safety and effectiveness of this product is unknown. All lots of the following dietary supplement products are being recalled. All of the products contain the activeâ€”yet undeclaredâ€”pharmaceutical ingredient sibutramine:
Slimbionic: 30 capsules/box
One Weight Loss Pill 30 capsules: 30 capsules/bottle
SlimDemand Capsules: 30 capsules/box
Botanical Weight Loss: 30 capsules/box
These recalled products were sold and distributed nationwide via the Internet and at the companyâ€™s Weight Loss and Rejuvenation Center in Tarzana.
The FDA is advising consumers that these products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for those with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. No illnesses or injuries have been reported to Young You, to date, in connection with this product.
The FDA is also advising consumers to destroy the recalled products or return them to the companyâ€™s address in Tarzana. Consumers may contact Young You Monday through Friday 9:00 am to 5:30 pm at 1-818-344-3344.
Opteron 1 Inc./DBA: Nature & Health Company
Opteron 1, which does business as (dba) as Nature & Health Co., issued a nationwide recall of a variety of its supplement products sold under the names LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, and Herbal Disiac.
The FDA advised Opteron 1/Nature & Health that its lab analysis of these five samples found they contains either tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED), its analog aminotadalafil, or the analog of sidenafil, an active ingredient of another FDA-approved ED drug, making these products unapproved drugs. None of the active drug ingredients are listed on the product labels. The following six recalled products were distributed in retail stores in California, Georgia, Illinois, Texas, and Ohio:
LibieXtreme: 1-capsule packet; active pharmaceutical ingredient aminotadafil
Y-4ever: 1-capsule packet; active pharmaceutical ingredient sulfoaidenafil
Libimax X Liquid: 1 fluid ounce packet; active pharmaceutical ingredient aminotadafil
Powermania liquid: 1 fluid ounce packet; active pharmaceutical ingredient sulfoaidenafil
Herbal Disiac: 40-capsule bottle; active pharmaceutical ingredient tadalafil
Powermania: 1-capsule packet; active pharmaceutical ingredient sulfoaidenafil
The FDA is advising consumers with these recalled products in their possession to stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. No illnesses have been reported to the company, to date, in connection with these products.
The FDA is also advising consumers to return any unused productsâ€”for a refund of the full purchase price or price for the unused portionâ€”to the retail location where they were purchased the recalled product or contact Nature & Health directly at 1-714-671-0016 Monday â€“ Friday, 8:00 am to 5:00 pm or by email at firstname.lastname@example.org to receive further instructions for returning the product or with any questions.
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 â€œall naturalâ€ 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 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.