Sunset Natural Products Recalls Karma Bulk Capsules Under Consent Decree
Sunset Natural Products Inc. is recalling Karma bulk capsules pursuant to a consent decree requiring the destruction of dietary supplements manufactured since April 2014.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary precautionary measure mandated by a consent decree to ensure cGMP compliance, with no specific reported illnesses or injuries in the source text.
Plain-English summary
Sunset Natural Products Inc. is recalling Karma, bulk capsules, pursuant to a consent decree entered on September 25, 2015. The decree 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. The recall involves 65,000 capsules, with a known lot number of 150414 and an expiration date of 04/17.
The products were distributed to Florida, Nevada, and the Dominican Republic. The consent decree requires the firm to hire a cGMP expert and receive written permission from the FDA to resume operations. The recall is being conducted under FDA supervision in accordance with the procedures provided in the decree.
Consumers who have purchased Karma bulk capsules should stop using the product and contact the recalling firm for further instructions. The recall is a precautionary measure mandated by the legal agreement to ensure compliance with current good manufacturing practices (cGMP).
The recalled product
- Product
- Karma, bulk capsules
- Manufacturer
- Sunset Natural Products Inc.
- Category
- Food — Dietary Supplement
- Affected units
- 65,000
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 # 150414 Exp. Date 04/17
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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