Sunset Natural Products Recalls Asey Dietary Supplement Under Consent Decree
Sunset Natural Products Inc. is recalling Asey Dietary Supplement pursuant to a consent decree requiring the destruction of products manufactured or distributed since April 2, 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 and the consent decree prohibiting future marketing.
Plain-English summary
Sunset Natural Products Inc. is recalling Asey Dietary Supplement (unknown container size) pursuant to a consent decree. 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's entry on September 25, 2015.
The recall is conducted under FDA supervision in accordance with the procedures outlined in the consent decree. The firm is also required to hire a cGMP expert and receive written permission from the FDA to resume operations. Known lots include #231114, 170315, and 310815.
Products were distributed to Florida, Nevada, and the Dominican Republic. Consumers should stop using the product and follow the instructions provided by the recalling firm or the FDA regarding disposal or return.
The recalled product
- Product
- Asey Dietary Supplement (unknown container size)
- Manufacturer
- Sunset Natural Products Inc.
- Category
- Food — Dietary Supplement
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 (13)
- 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: Lot # 231114
- 170315
- 310815
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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