Sunset Natural Products Recalls Bima Bulk Capsules Under Consent Decree
Sunset Natural Products Inc. is recalling Bima 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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the mandatory destruction of all products under a consent decree.
Plain-English summary
Sunset Natural Products Inc. is recalling 550,000 capsules of Bima, 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 they recall and destroy 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 affected products were distributed to Florida, Nevada, and the Dominican Republic. Known lots include Lot # 340414 (Exp. 05/17), Lot # 450514 (Exp. 06/17), Lot # 570614 (Exp. 06/17), and Lot # 230515 (Exp. 06/18). The consent decree also requires the firm to hire a cGMP expert and receive written permission from the FDA to resume operations.
Consumers who have these products should stop using them and follow the instructions provided by the recalling firm or the FDA for disposal or return, as the products are subject to destruction under FDA supervision.
The recalled product
- Product
- Bima, bulk capsules
- Manufacturer
- Sunset Natural Products Inc.
- Category
- Food — Dietary Supplement
- Affected units
- 550,000
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 (14)
- 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 # 340414 Exp. Date 05/17
- Lot # 450514 Exp. Date 06/17
- Lot # 570614 Exp. Date 06/17
- Lot # 230515 Exp. Date 06/18
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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