Sunset Natural Products Recalls Esclewe Dietary Supplement Under Consent Decree
Sunset Natural Products Inc. is recalling Esclewe Dietary Supplement 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, 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 Esclewe Dietary Supplement (unknown container size) 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, prepared, processed, packed, labeled, held, and/or distributed between April 2, 2014, and the date of the decree's entry. The recall is conducted under FDA supervision in accordance with the procedures provided in the decree.
The recall covers products distributed to Florida, Nevada, and the Dominican Republic. A known lot number is Lot # 340115. 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 Esclewe Dietary Supplement should stop using the product and contact Sunset Natural Products Inc. for further instructions or a refund, as directed by the recall notice.
The recalled product
- Product
- Esclewe 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 (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: Lot # 340115
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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