Opteron 1 Inc. dba Nature & Health Co., announced today that it is conducting a voluntary nationwide recall of the company’s five supplement products sold under the following names: LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, Herbal Disiac.
The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA 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 undeclared ingredients 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. Additionally, the product may cause side effects, such as headaches and flushing.
The six recalled products listed below were distributed in retail stores in California, Georgia, Illinois, Texas, and Ohio.
Brand Size Active Pharmaceutical Ingredient
LibieXtreme 1 Capsule Packet Aminotadafil
Y-4ever 1 Capsule Packet Sulfoaidenafil
Libimax X Liquid 1 Fl. Oz. Packet Aminotadafil
Powermania liquid 1 Fl. Oz. Packet Sulfoaidenafil
Herbal Disiac 40 capsule bottle Tadalafil
Powermania 1 Capsule Packet Sulfoaidenafil
Customers who have these products 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 the FDA’s MedWatch Adverse Event Reporting program online, by phone [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 which may be downloaded or by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].
No illnesses have been reported to the company to date in connection with these products.
If you or a family member has been injured because of the fault of someone else; by negligence, personal injury, slip and fall, car accident, medical malpractice, trucking accident, drunk driving, bad product, toxic injury etc then please contact the Fort Worth Texas Personal Injury Attorney Dr. Shezad Malik. For a no obligation, free case analysis, please call 817-255-4001 or Contact Me Online.