The Recall Desk
SevereFDA (Food)·F-0921-2017·Announced 2017-01-04

Sunset Natural Products Recalls Carni Care Dietary Supplement Under Consent Decree

Sunset Natural Products Inc. is recalling Carni Care dietary supplements pursuant to a consent decree requiring the destruction of products manufactured or distributed 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 all products under a consent decree.

Plain-English summary

Sunset Natural Products Inc. is recalling Carni Care, a dietary supplement sold in 50,000 capsule bulk containers, pursuant to a consent decree with the U.S. Food and Drug Administration. 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 the decree was entered on September 25, 2015.

The recall covers products distributed to Florida, Nevada, and the Dominican Republic. The source text identifies a known lot number 410415 with an expiration date of 04/18. The consent decree also requires the firm to hire a cGMP expert and receive written permission from the FDA to resume operations.

Consumers who have purchased Carni Care should stop using the product and contact Sunset Natural Products Inc. for further instructions on disposal or return, as the product must be destroyed under FDA supervision.

The recalled product

Product
Carni Care, (50,000 capsule bulk)
Affected units
50,000

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 and expiration date: Lot # 410415 Exp. Date 04/18

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 →