Prostax Forte recalled over manufacturing violations

Recall date

October 5, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Sunset Natural Products Inc. recalls Prostax Forte, sold in bulk of 50,000 capsules.

Recall number

F-0543-2016

FDA classification

Class II

Brand / firm

Sunset Natural Products Inc.

Sold / distributed

FL and NV

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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