The Recall Desk
SevereFDA (Food)·F-0930-2017·Announced 2017-01-04

Sunset Natural Products Recalls Colostrum Capsules Under Consent Decree

Sunset Natural Products Inc. is recalling 288 bottles of Colostrum capsules pursuant to a consent decree requiring the destruction of supplements 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 (score 4) under the provided rubric, particularly given the context of a consent decree involving cGMP violations.

Plain-English summary

Sunset Natural Products Inc. is recalling 288 bottles of Colostrum, 90 capsules per bottle, totaling 26,000 capsules. The recall is being conducted pursuant to a consent decree that prohibits the company and its owners from marketing dietary supplements until they recall and destroy the products manufactured or distributed since April 2, 2014, 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. Known lots include Lot # 201014 with an expiration date of 10/17 and Lot # 130115 with an expiration date of 01/18. The consent decree was entered on September 25, 2015.

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.

The recalled product

Product
Colostrum, 90 capsules per bottle
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 (12)

  • 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 # 201014 Exp. Date 10/17
  • Lot # 130115 Exp. Date 01/18

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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