Sunset Natural Products Recalls Natural Fat Burner Under Consent Decree
Sunset Natural Products Inc. is recalling Natural Fat Burner 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 under the rubric, particularly given the mandatory destruction of all products under a consent decree.
Plain-English summary
Sunset Natural Products Inc. is recalling Natural Fat Burner (45,000 capsule bulk) 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. A known lot number is 250715 with an expiration date of 07/18. 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 this product should stop using it and follow the instructions provided by the recalling firm or the FDA regarding the return or destruction of the product.
The recalled product
- Product
- Natural Fat Burner (45,000 capsule bulk)
- Manufacturer
- Sunset Natural Products Inc.
- Category
- Food — Dietary Supplement
- Affected units
- 45,000
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 # 250715 Exp. Date 07/18
Distribution
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.
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