The Recall Desk
ModerateFDA (Food)·F-0924-2017·Announced 2017-01-04

Sunset Natural Products Recalls Mdrol Dietary Supplement Under Consent Decree

Sunset Natural Products Inc. is recalling Mdrol dietary supplements pursuant to a consent decree requiring the destruction of products manufactured or distributed since April 2014.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is a voluntary precautionary action mandated by a consent decree to ensure compliance with cGMP regulations, with no specific reported illnesses or injuries cited in the source text.

Plain-English summary

Sunset Natural Products Inc. is recalling Mdrol, a dietary supplement sold in bottles of 90 capsules. The recall is being conducted pursuant to a consent decree entered on September 25, 2015, which prohibits the company and its owners from marketing dietary supplements until they recall and destroy all products manufactured, prepared, processed, packed, labeled, held, and/or distributed between April 2, 2014, and the date of the decree.

The recall covers 1,000 bottles, totaling 90,000 capsules. Known lot information includes Lot # 450615 with an expiration date of 07/18. The products were distributed to Florida, Nevada, and the Dominican Republic.

The consent decree requires the firm to hire a cGMP expert and receive written permission from the FDA to resume operations. Consumers should stop using the product and follow the instructions provided in the recall notice.

The recalled product

Product
Mdrol, 90 capsules per bottle
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplement
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • As persuant to the Consent Decree
  • the firm agreed to "recall and destroy
  • under FDA's supervision
  • in accordance with the procedures provided in paragraph 6
  • ALL dietary supplements that were manufactured
  • prepared
  • processed
  • packed
  • labeled
  • held and/or distributed between April 2
  • 2015. Known lot and expiration date: Lot # 450615 Exp. Date 07/18

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 163 recalled by Sunset Natural Products Inc. under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 163 products in this recall →

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