The Recall Desk
SevereFDA (Food)·F-1058-2017·Announced 2017-01-04

Sunset Natural Products Recalls Naer Dietary Supplement Under Consent Decree

Sunset Natural Products Inc. is recalling Naer Dietary Supplement 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, and the recall is mandated by a consent decree requiring the destruction of all products, which aligns with the 'Severe' criteria for significant regulatory action and potential risk.

Plain-English summary

Sunset Natural Products Inc. is recalling Naer Dietary Supplement (unknown container size) pursuant to a consent decree. The decree prohibits the company and its owners from marketing dietary supplements until they recall and destroy the products, hire a cGMP expert, and receive written permission from the FDA to resume operations.

The recall covers all dietary supplements manufactured, prepared, processed, packed, labeled, held, and/or distributed between April 2, 2014, and the date the decree was entered on September 25, 2015. The source text identifies Lot # 240515 as a known lot. Products were distributed to Florida, Nevada, and the Dominican Republic.

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

The recalled product

Product
Naer Dietary Supplement (unknown container size)
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: Lot # 240515

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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