Sunset Natural Products recalls Prostamax DUO dietary supplements manufactured since April 2014 due to FDA consent decree requirements. Consumers should stop using and destroy affected products.
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.
Sunset Natural Products is recalling Prostamax DUO dietary supplements produced since April 2014. This recall follows a consent decree with the FDA that requires the company to stop marketing supplements until they meet specific regulatory conditions.
The hazard is tied to a legal requirement from the FDA consent decree. The company must stop marketing supplements until they meet regulatory conditions, including hiring a cGMP expert and getting FDA approval to resume operations. This means the products are not safe for distribution under current conditions.
Anyone who purchased Prostamax DUO dietary supplements from April 2014 onward. People using these supplements for health purposes are most at risk due to the recall.
Check for Prostamax DUO capsules in bottles labeled '60 capsules per bottle'. Products manufactured since April 2014 with lot number 140515 and expiration date 05/18 are affected.
Immediately stop using and destroy all affected Prostamax DUO supplements.
Sunset Natural Products must recall these supplements as part of a consent decree with the FDA that requires them to stop marketing dietary supplements until they meet specific regulatory conditions.
Destroy all affected Prostamax DUO supplements immediately.
The affected products were manufactured since April 2, 2014.
We’ve drafted a message you can send Sunset Natural Products to request your refund or repair — edit it as you like.
Subject: Recall F-0542-2016 — Sunset Natural Products Sunset Natural Products Hello, I own a Sunset Natural Products that is covered by recall F-0542-2016 from Sunset Natural Products. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
