News, musings and commentary on dietary supplements & pharmaceutical law issues, technology, and litigation.
Lawyers for consumers and injured people.(No advice on this blog, though)
Wednesday, March 23, 2011
Nationwide Recall of U-Prosta, a Product Marketed As a Dietary Supplement That Contains Undeclared Terazosin Hydrochloride
From the FDA:
There is a nationwide recall of the Company's supplement product sold under the name “U-Prosta Natural support for prostate health”. The Company has been informed by representatives of the U.S. Food and Drug Administration (FDA) that 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. No illnesses have been reported to the company to date in connection with this product.