ISSUE: USA Far Ocean Group, Inc. issues voluntary nationwide recall of U-Prosta, a product marketed as a dietary supplement that contains undeclared terazosin hydrochloride. Lab analysis by FDA of U-Prosta samples found the product contains terazosin, the active ingredient of an FDA-approved drug used to treat Benign Prostatic Hyperplasia (enlarged prostate), making U-Prosta an unapproved drug. The most likely adverse health consequences that could occur with the use of this product would be hypotension, dizziness, or syncope. Patients who are currently being treated with prescription medications for high blood pressure or enlarged prostate would be at increased risk of these events. In these patients, the hypotensive events may be more severe.
BACKGROUND: The product is sold under the name “U-Prosta Natural support for prostate health”. The product has been distributed nationwide via retail stores, internet sales and mail order. All of the following U-Prosta products, which are packaged in white plastic bottles & 1 capsule blister pack, are involved in this voluntary recall.
RECOMMENDATION: The recalled lots are listed in the firm's press release below. Consumers in possession of the affected product are urged to stop using it immediately and return it to the place of purchase for a full refund. Consumers should contact their physician if they have experienced any problem that may be related to taking this product.
Healthcare professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[03/23/2011 - Firm Press Release - USA Far Ocean Group]