PlainRecalls
FDA Food Moderate Class II Terminated

Prostax Forte, sold in bulk of 50,000 capsules.

Reported: February 24, 2016 Initiated: October 5, 2015 #F-0543-2016

Product Description

Prostax Forte, sold in bulk of 50,000 capsules.

Reason for Recall

Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.

Details

Units Affected
50,000 capsules
Distribution
FL and NV
Location
Miami, FL

Frequently Asked Questions

What product was recalled?
Prostax Forte, sold in bulk of 50,000 capsules.. Recalled by Sunset Natural Products Inc.. Units affected: 50,000 capsules.
Why was this product recalled?
Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
Which agency issued this recall?
This recall was issued by the FDA Food on February 24, 2016. Severity: Moderate. Recall number: F-0543-2016.