Sunset Natural Products Inc. recalls Esclewe dietary supplements manufactured from April 2, 2014, due to a consent decree with FDA requiring destruction. All units produced since that date must be destroyed under FDA supervision.
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 manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
Sunset Natural Products is recalling all Esclewe dietary supplements made from April 2, 2014, because the company violated FDA regulations and must destroy them as part of a consent decree. This recall affects anyone who owns these supplements.
The company violated FDA regulations by marketing dietary supplements without proper oversight. As a result, the products must be destroyed under FDA supervision to comply with a consent decree that prohibits the company from marketing supplements until they meet specific requirements.
Anyone who owns or uses Esclewe dietary supplements manufactured from April 2, 2014, through September 25, 2015. People who have these products are most at risk.
Look for Esclewe dietary supplements with a lot number of 340115. The products were manufactured between April 2, 2014, and September 25, 2015.
Destroy all Esclewe dietary supplements manufactured from April 2, 2014, through September 25, 2015, as required by the FDA consent decree.
Sunset Natural Products Inc. violated FDA regulations and must destroy all Esclewe dietary supplements made from April 2, 2014, through September 25, 2015, as part of a consent decree.
Destroy all Esclewe dietary supplements manufactured from April 2, 2014, through September 25, 2015, as required by the FDA consent decree.
Yes, the recalled products have a lot number of 340115.
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-1045-2017 — Sunset Natural Products Sunset Natural Products Hello, I own a Sunset Natural Products that is covered by recall F-1045-2017 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.
