The Recall Desk
SevereFDA (Food)·F-0963-2017·Announced 2017-01-04

Sunset Natural Products Recalls Colageina Orange Dietary Supplement Jars

Sunset Natural Products Inc. is recalling Colageina Orange 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. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when associated with significant regulatory actions like consent decrees requiring destruction of inventory.

Plain-English summary

Sunset Natural Products Inc. is recalling Colageina Orange dietary supplements, packaged in 195 g jars. The recall involves 5,812 jars distributed to Florida, Nevada, and the Dominican Republic. Specific lot numbers and expiration dates are listed in the source metadata, including lots expiring between October 2017 and May 2018.

This recall is being conducted 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 or distributed since April 2, 2014, hire a cGMP expert, and receive written permission from the FDA to resume operations.

Consumers who have purchased these products should stop using them and follow the instructions provided by the recalling firm or the FDA regarding disposal or return.

The recalled product

Product
Colageina Orange, (195 g per Jar)

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 (17)

  • 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 # 271014 Exp. Date 10/17
  • Lot # 281014 Exp. Date 12/17
  • Lot # 291014 Exp. Date 03/18
  • Lot # 301014 Exp. Date 04/18
  • Lot # 311014 Exp. Date 05/18
  • Lot # 230615 Exp. Date 05/18
  • Lot # 301114 Exp. Date 11/17

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 →