Sunset Natural Products Recalls Aloe Vera Dietary Supplements Under Consent Decree
Sunset Natural Products Inc. is recalling Aloe Vera dietary supplements 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 context of a consent decree requiring the destruction of all products manufactured over a three-year period.
Plain-English summary
Sunset Natural Products Inc. is recalling Aloe Vera, 25 mg, Dietary Supplements 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. Known lot numbers include 490814, 141015, 161114, and 171114. The source text does not specify the container size or the total quantity of units affected.
Consumers who have purchased these products should stop using them and follow the instructions provided by the recalling firm or the FDA regarding the destruction of the supplements under FDA supervision.
The recalled product
- Product
- Aloe Vera, 25 mg, 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 (14)
- 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 # 490814
- 141015
- 161114
- 171114
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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