Sunset Natural Products Recalls Madre Cell Dietary Supplement
Sunset Natural Products Inc. is recalling Madre Cell 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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), regardless of the specific hazard details provided in the text.
Plain-English summary
Sunset Natural Products Inc. is recalling Madre Cell, 60 capsules per bottle, pursuant to a consent decree with the U.S. Food and Drug Administration. 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, or distributed between April 2, 2014, and the date of the decree's entry on September 25, 2015.
The recall covers 1,000 bottles (60,000 capsules) distributed to Florida, Nevada, and the Dominican Republic. Known lots include Lot # 510315 with an expiration date of 04/18 and Lot # 410815 with an expiration date of 09/18. 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 purchased these products should stop using them and follow the instructions provided by the recalling firm or the FDA for disposal or return.
The recalled product
- Product
- Madre Cell, 60 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 (12)
- 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 # 510315 Exp. Date 04/18
- Lot # 410815 Exp. Date 09/18
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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