Sunset Natural Products recalls SoMaks dietary supplements manufactured from April 2, 2014, due to a consent decree requiring destruction 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 SoMaks dietary supplements produced from April 2, 2014, because the company violated FDA regulations and must destroy all recalled products under a consent decree.
The hazard stems from the company's failure to comply with FDA regulations, which led to a consent decree requiring the destruction of all recalled products. The specific risk is not detailed in the recall notice, but the company must destroy products under FDA supervision to avoid further regulatory issues.
Owners of SoMaks dietary supplements purchased between April 2, 2014, and September 25, 2015, are affected. People who consumed these products may be at risk due to the company's regulatory violations.
Check for SoMaks dietary supplements with lot number 300415 and expiration date July 18, 2018. Products manufactured between April 2, 2014, and September 25, 2015, are affected.
Identify SoMaks capsules with lot number 300415 and expiration date July 18, 2018.
Destroy the recalled SoMaks capsules under FDA supervision as required by the consent decree.
Sunset Natural Products violated FDA regulations and must destroy all products manufactured between April 2, 2014, and September 25, 2015, as part of a consent decree.
Check for SoMaks capsules with lot number 300415 and expiration date July 18, 2018, manufactured between April 2, 2014, and September 25, 2015.
Destroy the product under FDA supervision as required by the consent decree.
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-0911-2017 — Sunset Natural Products Sunset Natural Products Hello, I own a Sunset Natural Products that is covered by recall F-0911-2017 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.
