The Recall Desk
SevereFDA (Food)·F-1068-2017·Announced 2017-01-04

Sunset Natural Products Recalls Colageina Dietary Supplements Under Consent Decree

Sunset Natural Products Inc. is recalling Colageina 10 Caps 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 products under a consent decree.

Plain-English summary

Sunset Natural Products Inc. is recalling Colageina 10 Caps dietary supplements. This action is being taken pursuant to a consent decree that 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. Known lot numbers include 160415, 270415, 280415, 290415, 550615, 560615, 570615, 580615, 350815, and 360815. The products were distributed to Florida, Nevada, and the Dominican Republic.

Consumers who have purchased these products should stop using them and contact the recalling firm or the FDA for further instructions regarding the destruction of the supplements.

The recalled product

Product
Colageina 10 Caps, 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 (20)

  • 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 # 160415
  • 270415
  • 280415
  • 290415
  • 550615
  • 560615
  • 570615
  • 580615
  • 350815
  • 360815

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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