Sunset Natural Products Recalls Tevass Dietary Supplement Under Consent Decree
Sunset Natural Products Inc. is recalling Tevass 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 products under a consent decree.
Plain-English summary
Sunset Natural Products Inc. is recalling Tevass Dietary Supplement of unknown container size. The recall is being conducted pursuant to a consent decree that prohibits the company and its owners from marketing dietary supplements until specific conditions are met. These conditions include the recall and destruction of all dietary supplements 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 consent decree also requires the firm to hire a cGMP expert and receive written permission from the FDA to resume operations. The known lot number for this recall is 080115. The products were distributed to Florida, Nevada, and the Dominican Republic.
Consumers who have purchased Tevass Dietary Supplement should stop using the product and contact Sunset Natural Products Inc. for further instructions on disposal or return, in accordance with the consent decree procedures.
The recalled product
- Product
- Tevass 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 # 080115
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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