Sunset Natural Products Recalls Abte Bulk Capsules Under Consent Decree
Sunset Natural Products Inc. is recalling Abte bulk capsules pursuant to a consent decree requiring the destruction of dietary 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. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when associated with significant regulatory actions like consent decrees requiring destruction of products.
Plain-English summary
Sunset Natural Products Inc. is recalling Abte bulk 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 conditions are met.
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. The known lot number is 040714 with an expiration date of 07/17.
The 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 regarding disposal or return.
The recalled product
- Product
- Abte, bulk capsules
- Manufacturer
- Sunset Natural Products Inc.
- Category
- Food — Dietary Supplement
- Affected units
- 60,000
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 # 040714 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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