Sunset Natural Products Recalls Super Inmuno Dietary Supplement Under Consent Decree
Sunset Natural Products Inc. is recalling Super Inmuno Dietary Supplement pursuant to a consent decree requiring the destruction of products manufactured since April 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, and the recall is mandated by a consent decree requiring the destruction of all products manufactured over a three-year period, which aligns with the 'Severe' criteria for significant regulatory enforcement actions.
Plain-English summary
Sunset Natural Products Inc. is recalling Super Inmuno Dietary Supplement 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 consent 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 decree also requires the company to hire a cGMP expert and receive written permission from the FDA to resume operations. Known lot number 061014 is included in this recall.
Products were distributed to Florida, Nevada, and the Dominican Republic. Consumers who possess this product should stop using it and follow the instructions provided by the recalling firm or the FDA regarding disposal.
The recalled product
- Product
- Super Inmuno 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 # 061014
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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