Terminated Class II

Sunset Natural Products Inc.

Recall F-0932-2017 · Miami, FL

Product

Liver Energy, 100 capsules per bottle

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.

Distribution

Products distributed to Florida, Nevada and the Dominican Republic

Quantity affected

124 Bottles (18,000 capsules)

Recall type

FDA Mandated

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 and expiration date: Lot # 200115 Exp. Date 01/18

Timeline

13 Oct 2015 initiated 28 Dec 2016 classified 4 Jan 2017 reported 10 Apr 2017 terminated

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