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Nature & Health Co., announced a voluntary nationwide recall of the company's supplement products sold under the following names: LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, Herbal Disiac. Lab analysis by FDA of these products found they contain either tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED), its analog aminotadalafil, or the analog of sildenafil, an active ingredient of another FDA-approved ED drug, making these products unapproved drugs. The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. 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 these products.
Read the 2009 MedWatch safety summary, including a link to the company's Press Release, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
