Sunset Natural Products Recalls Amitad Dietary Supplement Under Consent Decree
Sunset Natural Products Inc. is recalling Amitad 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 score of 4 (Severe) per the rubric, as it involves a significant risk of temporary or medically reversible adverse health consequences.
Plain-English summary
Sunset Natural Products Inc. is recalling Amitad 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 firm must also hire a cGMP expert and receive written permission from the FDA to resume operations.
The recall covers products distributed to Florida, Nevada, and the Dominican Republic. A known lot number is Lot # 160514. The source text does not specify the total number of units affected or report any specific illnesses or injuries associated with the product.
Consumers who have purchased Amitad Dietary Supplement should stop using the product and follow the instructions provided in the consent decree or contact the recalling firm for further guidance on destruction or return.
The recalled product
- Product
- Amitad 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 # 160514
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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