The Recall Desk
SevereFDA (Food)·F-0935-2017·Announced 2017-01-04

Sunset Natural Products Recalls Argindione Dietary Supplement Under Consent Decree

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

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the context of a consent decree requiring the destruction of all products manufactured over a three-year period.

Plain-English summary

Sunset Natural Products Inc. is recalling Argindione, a dietary supplement, pursuant to a consent decree with the U.S. Food and Drug Administration. The decree 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's entry on September 25, 2015. The firm is also required to hire a cGMP expert and receive written permission from the FDA to resume operations.

The recall covers 50,000 capsules of Argindione. Known lot information includes Lot # 520414 with an expiration date of 04/17. The products were distributed to Florida, Nevada, and the Dominican Republic.

Consumers who have purchased this product should stop using it and follow the instructions provided by the recalling firm or the FDA regarding the return or destruction of the product.

The recalled product

Product
Argindione, (50,000 capsule bulk)
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplement
Hazard
Affected units
50,000

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 # 520414 Exp. Date 04/17

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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