Sunset Natural Products Recalls Enma Dietary Supplement Under Consent Decree
Sunset Natural Products Inc. is recalling Enma 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, and the recall is mandated by a consent decree prohibiting future marketing until corrective actions are completed, which aligns with the 'Severe' criteria for significant regulatory enforcement actions.
Plain-English summary
Sunset Natural Products Inc. is recalling Enma Dietary Supplement of unknown container size. This action is taken pursuant to a consent decree entered on September 25, 2015, which prohibits the company and its owners from marketing dietary supplements until specific conditions are met.
The consent decree requires the firm to recall and destroy, under FDA supervision, all dietary supplements manufactured, prepared, processed, packed, labeled, held, and/or distributed between April 2, 2014, and the date of the decree's entry. The firm must also hire a cGMP expert and receive written permission from the FDA to resume operations. Known lot numbers include 260615, 200715, and 490815.
Products were distributed to Florida, Nevada, and the Dominican Republic. Consumers should stop using the product and follow the instructions provided in the consent decree regarding the recall and destruction process.
The recalled product
- Product
- Enma 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 # 260615
- 200715
- 490815
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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