The Recall Desk
SevereFDA (Food)·F-1063-2017·Announced 2017-01-04

Sunset Natural Products Recalls Welca Dietary Supplement Under Consent Decree

Sunset Natural Products Inc. is recalling Welca 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, which corresponds to a severity score of 4 (Severe) per the rubric, as it involves a significant risk of temporary or medically reversible adverse health consequences.

Plain-English summary

Sunset Natural Products Inc. is recalling Welca 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 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 recall is part of a legal agreement requiring the firm to hire a cGMP expert and receive written permission from the FDA to resume operations. Known lot number 460615 is included in the recall. The products were distributed to Florida, Nevada, and the Dominican Republic.

Consumers who have purchased Welca Dietary Supplement should stop using the product and contact Sunset Natural Products Inc. for further instructions. The recall is being conducted under FDA supervision in accordance with the procedures provided in the consent decree.

The recalled product

Product
Welca 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 # 460615

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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