Sunset Natural Products Recalls Insulow Dietary Supplement Under Consent Decree
Sunset Natural Products Inc. is recalling Insulow Dietary Supplement pursuant to a consent decree requiring the destruction of products manufactured or distributed 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, and the recall is mandated by a consent decree requiring the destruction of all products, which aligns with the 'Severe' criteria for significant regulatory action and potential risk.
Plain-English summary
Sunset Natural Products Inc. is recalling Insulow Dietary Supplement 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 or distributed since April 2, 2014, 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. The known lot number is 480815. The consent decree was entered on September 25, 2015.
Consumers who have purchased Insulow 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
- Insulow 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 # 480815
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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