The Survive and Thrive Boomer Guide Recall of the Week: Nature & Health Co. male enhancement products
July 20, 2009
Opteron 1 Inc., doing business as Nature & Health Co., is conducting a voluntary nationwide recall of the company's six supplement products sold under the following names: LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid, Powermania Capsule, and Herbal Disiac.
A U.S. Food and Drug Administration lab analysis of samples of the supplements found they contain either tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction or ED, its analog aminotadalafil, or the analog of sidenafil, an active ingredient of another FDA-approved ED drug.
An analog is a drug whose structure is related to that of another drug but whose chemical and biological properties may be quite different.
The recalled products are unapproved drugs, according to the FDA.
None of the active drug ingredients are listed on the product labels, reports the FDA. 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.
In addition, the product may cause side effects, such as headaches and flushing.
The six recalled products were distributed in retail stores in California, Georgia, Illinois, Texas, and Ohio.
Consumers who have any these products in their possession should stop using them immediately and contact their physician if they’ve experienced any problems that may be related to taking the products, recommends the FDA.
Any adverse events that may have been caused by the use of the products should be reported to the FDA's MedWatch Adverse Event Reporting program:
- Online at www.fda.gov/MedWatch/report.htm.
- By phone at 800-FDA-1088.
- By returning the postage-paid FDA form 3500, which may be downloaded from www.fda.gov/MedWatch/getforms.htm, by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.
- By fax at 800-FDA-0178.
No illnesses have been reported to the company in connection with these products, the FDA reports.
Consumers should return any unused products – for a refund of the full purchase price or a refund of the cost for the unused portion – to the retail location where they were purchased.
Or contact Nature & Health directly at 714-671-0016 Monday through Friday from 8 a.m. to 5 p.m. or by email at firstname.lastname@example.org to receive further instructions for returning the product or with any questions.
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