Sunset Natural Products Inc. is recalling Heci dietary supplements made from April 2, 2014, due to a consent decree with FDA requiring destruction. All affected lots 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 Heci dietary supplements manufactured or distributed since April 2, 2014. This recall follows a consent decree with the FDA that prohibits the company from marketing supplements until they destroy all affected products and meet regulatory requirements.
The hazard is that the company violated FDA regulations by marketing dietary supplements without proper oversight. This led to a consent decree requiring the company to destroy all affected products and get FDA approval before resuming operations.
Anyone who purchased Heci dietary supplements from April 2, 2014, onward is affected. People who have the products must destroy them as part of the recall.
Check for Heci dietary supplements with lot numbers 500814, 071214, 040415, or 330615. Products manufactured or distributed from April 2, 2014, onward are affected.
Heci dietary supplements with the listed lot numbers must be destroyed under FDA supervision.
The company violated FDA regulations and must destroy all affected products as part of a consent decree to stop marketing supplements until they meet regulatory requirements.
Lot numbers 500814, 071214, 040415, and 330615 are affected.
The recall was issued on September 25, 2015, following a consent decree entered that day.
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-1031-2017 — Sunset Natural Products Sunset Natural Products Hello, I own a Sunset Natural Products that is covered by recall F-1031-2017 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.