Sunset Natural Products Recalls H-Stane Dietary Supplement Under Consent Decree
Sunset Natural Products Inc. is recalling H-Stane 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, which corresponds to a Severe rating (Score 4) under the rubric, particularly given the mandatory nature of the recall under a consent decree.
Plain-English summary
Sunset Natural Products Inc. is recalling H-Stane, 60 capsules per bottle, pursuant to a consent decree with the U.S. Food and Drug Administration. The recall covers 500 bottles (30,000 capsules) of the dietary supplement. The specific lot number is 170515 with an expiration date of 05/18.
The recall is mandated by a consent decree that 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 decree also requires the firm to hire a cGMP expert and receive written permission from the FDA to resume operations.
The affected products were distributed to Florida, Nevada, and the Dominican Republic. Consumers should stop using the recalled product and follow the instructions provided by the recalling firm or the FDA for disposal or return.
The recalled product
- Product
- H-Stane, 60 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 lot and expiration date: Lot # 170515 Exp. Date 05/18
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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