Sunset Natural Products Inc. recalls Mdrol dietary supplements manufactured from April 2, 2014, under an FDA consent decree requiring destruction of all 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 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 Mdrol dietary supplements produced from April 2, 2014, because the company violated FDA regulations and must destroy all affected products as part of a consent decree. This recall affects consumers who own these supplements and requires immediate action to prevent potential regulatory violations.
The hazard stems from the company's violation of FDA regulations, which led to a consent decree requiring the destruction of all affected products. This is not a safety hazard but a regulatory compliance issue that the company must address to resume operations.
Anyone who owns Mdrol supplements manufactured from April 2, 2014, through the date of the consent decree. Consumers who have these products are most at risk of needing to destroy them to comply with the FDA decree.
Check for Mdrol supplements with lot number 450615 and expiration date July 18, 2018, manufactured from April 2, 2014, through the decree entry date of September 25, 2015.
Identify if your Mdrol supplement has lot number 450615 and expiration date July 18, 2018, manufactured between April 2, 2014, and September 25, 2015.
If you have the recalled product, destroy it immediately to comply with the FDA consent decree.
Sunset Natural Products Inc. violated FDA regulations and must destroy all affected products as part of a consent decree to comply with FDA requirements.
Destroy the product immediately to comply with the FDA consent decree.
The recall was issued on September 25, 2015, when the consent decree was entered.
No, the recall is due to regulatory compliance, not a safety hazard.
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-0924-2017 — Sunset Natural Products Sunset Natural Products Hello, I own a Sunset Natural Products that is covered by recall F-0924-2017 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.
