Sunset Natural Products Recalls Blanc Dietary Supplement Under Consent Decree
Sunset Natural Products Inc. is recalling Blanc Dietary Supplement pursuant to a consent decree requiring the destruction of products manufactured or distributed since April 2, 2014.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls without specific hospitalization reports or structural defects fall into the High severity category, particularly when the hazard is not explicitly detailed as a high-risk pathogen or allergen but involves a regulatory enforcement action.
Plain-English summary
Sunset Natural Products Inc. is recalling Blanc Dietary Supplement (unknown container size) pursuant to a consent decree with the U.S. Food and Drug Administration. 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 on September 25, 2015. The firm is also required to 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 number 381214 is identified in the recall documentation. The source text does not specify a particular health hazard, illness, or injury associated with the product; the recall is driven by the legal requirements of the consent decree.
Consumers who have purchased Blanc Dietary Supplement should stop using the product and follow the instructions provided by the recalling firm or the FDA regarding disposal or return.
The recalled product
- Product
- Blanc 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 # 381214
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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