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Class II

Sunset Natural Products Inc.

Recall #F-1028-2017 · Initiated 2015-10-13

Plain-language summary

by FoodRecallsDB.info
What happened
Sunset Natural Products Inc. has been ordered by the FDA to recall their Resvence Dietary Supplement due to the company violating manufacturing standards and safety requirements. The company is prohibited from selling dietary supplements until they meet specific safety conditions.
Who is at risk
Anyone who purchased Resvence Dietary Supplement in Florida, Nevada, or the Dominican Republic should be aware of this recall.
What to do
If you have this product, stop using it and contact the manufacturer or your retailer for instructions on how to return it. You can also check the FDA website for more information about this recall.
Product
Resvence Dietary Supplement (unknown container size)
Reason for recall
Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
Quantity affected
Unknown
Distribution
Products distributed to Florida, Nevada and the Dominican Republic
Lot / code info
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, 2014 and the date of entry of this Decree." The Decree was entered on September 25, 2015. Known lot: Lot # 230614, 430714, 170914, 460914, 451014, 201214, 321214, 400614, 300215, 230415
Voluntary / mandated
FDA Mandated
Initial notification
Letter
Terminated
2017-04-10

Recalling firm

Sunset Natural Products Inc.
7345 SW 45th St
Miami, FL 33155-4509
United States

Recall classification

Remote probability of serious adverse health consequences, or temporary reversible consequences.

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