The Recall Desk
SevereFDA (Food)·F-1023-2017·Announced 2017-01-04

Sunset Natural Products Recalls Ginseng Dietary Supplements Under Consent Decree

Sunset Natural Products Inc. is recalling ginseng 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 mandatory destruction of all products and the legal prohibition on marketing until compliance is verified.

Plain-English summary

Sunset Natural Products Inc. is recalling ginseng dietary supplements of unknown container size. This action is being taken pursuant to a consent decree that prohibits the company and its owners from marketing dietary supplements until specific conditions are met.

The consent decree requires the firm to recall and destroy 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 decree also requires the company to hire a cGMP expert and receive written permission from the FDA to resume operations. Known lot number 040515 is included in this recall.

Products were distributed to Florida, Nevada, and the Dominican Republic. Consumers should stop using the recalled products and follow the instructions provided by the recalling firm or the FDA regarding disposal or return.

The recalled product

Product
Ginseng 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 # 040515

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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