Sunset Natural Products Recalls Performens Dietary Supplement Under Consent Decree
Sunset Natural Products Inc. is recalling Performens dietary supplements 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 prohibiting future marketing until specific corrective actions are taken, which aligns with the 'Severe' criteria for significant regulatory intervention and potential non-compliance risks.
Plain-English summary
Sunset Natural Products Inc. is recalling Performens, 30 capsules per bottle, 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 recall also requires the firm to hire a cGMP expert and receive written permission from the FDA to resume operations.
The recall involves 2,000 bottles (120,000 capsules) of Performens. Known lot information includes Lot # 390614 with an expiration date of 07/17. The products were distributed to Florida, Nevada, and the Dominican Republic.
Consumers who have purchased this product should stop using it and follow the instructions provided by the recalling firm or the FDA for disposal or return, as required by the consent decree.
The recalled product
- Product
- Performens, 30 capsules per bottle
- 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 lots and expiration dates: Lot # 390614 Exp. Date 07/17
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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