Sunset Natural Products Recalls Bionix Dietary Supplement Under Consent Decree
Sunset Natural Products Inc. is recalling Bionix dietary supplements pursuant to a consent decree requiring the destruction of products manufactured 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 manufactured over a three-year period, indicating significant regulatory non-compliance and potential risk.
Plain-English summary
Sunset Natural Products Inc. is recalling Bionix, a dietary supplement sold in bottles of 30 capsules. The recall is being conducted pursuant to a consent decree entered on September 25, 2015, which prohibits the company and its owners from marketing dietary supplements until specific corrective actions are completed.
The consent decree requires the firm to recall and destroy, under FDA supervision, all dietary supplements manufactured, prepared, processed, packed, labeled, held, and/or distributed between April 2, 2014, and the date of the decree. The firm must also hire a cGMP expert and receive written permission from the FDA to resume operations. The recall covers 6,500 bottles (195,000 capsules) of Bionix.
Products were distributed to Florida, Nevada, and the Dominican Republic. Known lot numbers include #380414 (Exp 04/17), #310614 (Exp 07/17), and #391014 (Exp 12/17). Consumers should stop using the product and follow the instructions provided by the recalling firm or the FDA.
The recalled product
- Product
- Bionix, 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 (13)
- 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 exp date: Lot # 380414 Exp Date 04/17
- Lot #310614 Exp Date 07/17
- Lot # 391014 Exp Date 12/17
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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