The Recall Desk
SevereFDA (Food)·F-0959-2017·Announced 2017-01-04

Sunset Natural Products Recalls Colageina Gold Dietary Supplement Jars

Sunset Natural Products Inc. is recalling Colageina Gold 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 severity score (4) according to the rubric, as it involves a significant health risk or temporary/reversible adverse health consequences.

Plain-English summary

Sunset Natural Products Inc. is recalling 10,663 jars of Colageina Gold, 195 g, pursuant to a consent decree entered on September 25, 2015. 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. The company is also required to hire a cGMP expert and receive written permission from the FDA to resume operations.

The affected products were distributed to Florida, Nevada, and the Dominican Republic. Specific lot numbers and expiration dates are listed in the recall documentation, including lots expiring between August 2014 and September 2018.

Consumers who have purchased these products should stop using them and follow the instructions provided by the recalling firm or the FDA for disposal or return, as the recall is being conducted under FDA supervision.

The recalled product

Product
Colageina Gold, 195 g Jars
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplement
Hazard
Affected units
10,663

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 lots and expiration dates: Lot # 230514 Exp. Date 06/17
  • Lot # 330614 Exp. Date 06/17
  • Lot # 500714 Exp. Date 09/17
  • Lot # 510714 Exp. Date 10/17
  • Lot # 520714 Exp. Date 11/17
  • Lot # 360914 Exp. Date 07/18
  • Lot # 430814 Exp. Date 08/16
  • Lot # 450814 Exp. Date 08/14
  • Lot # 330914 Exp. Date 09/16
  • Lot # 340914 Exp. Date 09/16

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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