Sunset Natural Products Recalls Crea Care Dietary Supplement Capsules
Sunset Natural Products Inc. is recalling Crea Care capsules pursuant to a consent decree requiring the destruction of supplements 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, which aligns with the 'Severe' criteria for significant regulatory action and potential risk.
Plain-English summary
Sunset Natural Products Inc. is recalling Crea Care, a dietary supplement available in 100,000 capsule bulk quantities. 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's entry. The firm must also hire a cGMP expert and receive written permission from the FDA to resume operations. Known lot information includes Lot # 400415 with an expiration date of 04/18.
The products were distributed to Florida, Nevada, and the Dominican Republic. Consumers who possess the recalled product should stop using it and follow the instructions provided by the recalling firm or the FDA for disposal or return.
The recalled product
- Product
- Crea Care, (100,000 capsule bulk)
- Manufacturer
- Sunset Natural Products Inc.
- Category
- Food — Dietary Supplement
- Affected units
- 100,000
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 # 400415 Exp. Date 04/18
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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