USA Far Ocean Group (Alhambra, CA) voluntarily recalled their product, U-Prosta, a dietary supplement for prostate health on March 22, 2011.
USA Far Ocean Group was informed by the Food and Drug Administration (FDA) that laboratory analyses of U-Prosta revealed samples of the product contained terazosin, an active ingredient of an FDA-approved drug to treat Benign Prostatic Hyperplasia (enlarged prostate), making U-Prosta an unapproved drug.
Patients presently being treated for high blood pressure or enlarged prostate who take U-Prosta could experience some adverse affects, such as hypotension, dizziness or syncope. Thus far, no illnesses resulting from use have been reported to USA Far Ocean Group. But U-Prosta, has been sold and distributed nationwide through retails stores, Internet sales and by mail order. The U-Prosta products involved in this recall have the following UPC Codes:
U-Prosta Dietary Supplement 60 Capsules 689076499255
U-Prosta Dietary Supplement 30 Capsules 88858100030
U-Prosta Dietary Supplement 1 Capsule No UPC Code
According to the recall,
consumers of U-Prosta have been urged to stop using it immediately and return it to the place of purchase for a full refund. Consumers with questions may contact USA Far Ocean Group’s recall number at (626) 576-1299, Monday – Sunday, 9 a.m. – 5 p.m. Pacific Time. Consumers experiencing any problem that could be related to taking U-Prosta should contact their physician. Adverse reactions experienced with the use of this product should be reported to the FDA’s MedWatch Program either online at www.fda.gov/medwatch/report.htm or by phone: (800)FDA-1088 or by FAX 1-800-FDA-0178.
The FDA analysis and recall of U-Prosta may have spurred the FDA to scrutinize more closely the contents of other USA Far Ocean Group products, and on March 29, 2011, FAR Ocean Group also recalled their supplement product, "X-Hero/Male Enhancer" because "lab analysis by FDA of X-Hero sample found the product contains sulfosildenafil, the analogue of the active ingredient of an FDA-approved drug used to treat erectile dysfunction (ED), making X-Hero an unapproved drug. In addition, FDA analysis of Male Enhancer sample found the product contains tadalafil, the active ingredient of an FDA-approved drug used to treat erectile dysfunction (ED), making the Male Enhancer an unapproved drug.
According to the FDA, both products pose a threat to consumers because they may interact with nitrates found in prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. According to the FDA, consumers with diabetes, high blood pressure, high cholesterol, or heart disease who often take nitrates and may be at risk if they use the X-Hero or Male Enhancer products produced by USA Far Ocean Group.