USA Far Ocean Group is the maker of the product, and it was told by the 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 treated for high blood pressure or enlarged prostate who taking U-Prosta could experience some adverse affects, such as hypotension, dizziness or syncope.
Low blood pressure, or hypotension, occurs when blood pressure during and after each heartbeat is much lower than usual. This means the heart, brain, and other parts of the body do not get enough blood.
Syncope (SIN'ko-pe) is temporary loss of consciousness and posture, described as "fainting" or "passing out.
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 are:
U-Prosta Dietary Supplement 60 Capsules 689076499255
U-Prosta Dietary Supplement 30 Capsules 88858100030
U-Prosta Dietary Supplement 1 Capsule No UPC Code
