Sunset Natural Products Recalls Bioxtron Dietary Supplements Under Consent Decree
Sunset Natural Products Inc. is recalling Bioxtron Dietary Supplements pursuant to a consent decree requiring the destruction of products manufactured or distributed since April 2, 2014.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 (Score 4) in the rubric, particularly given the mandatory nature of the recall under a consent decree.
Plain-English summary
Sunset Natural Products Inc. is recalling Bioxtron Dietary Supplements of unknown container size. This action is taken pursuant to a consent decree that prohibits the company and its owners from marketing dietary supplements until specific conditions are met. The decree requires the firm to recall and destroy all dietary supplements manufactured, prepared, processed, packed, labeled, held, and/or distributed between April 2, 2014, and the date the decree was entered on September 25, 2015.
The recall covers products distributed to Florida, Nevada, and the Dominican Republic. The source text lists numerous specific lot numbers associated with this recall, including Lot # 190414, 210414, and 220414, among others. The decree also requires the firm to hire a cGMP expert and receive written permission from the FDA to resume operations.
Consumers who have purchased Bioxtron Dietary Supplements from Sunset Natural Products Inc. should stop using the product. The source text does not specify a particular consumer action such as returning the product to a retailer or contacting a specific phone number, but the recall is mandated by the consent decree to ensure compliance with FDA regulations.
The recalled product
- Product
- Bioxtron 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 (20)
- 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 # 190414
- 210414
- 220414
- 230414
- 280514
- 290514
- 300514
- 310514
- 490514
- 290614
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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