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Sunset Natural Products Inc. Recall 74054

Description: Oxy Extreme, 90 capsules per bottle

Sunset Natural Products Inc. Recall 74054 Information

Recall StatusTerminated
Recall Event ID74054
Recall NumberF-0915-2017
Recall DateOctober 13, 2015
DistributionProducts distributed to Florida, Nevada and the Dominican Republic
Quantity1,200 bottles (108,000 capsules)
Recall Mandatory?FDA Mandated
Product TypeFood
Food ClassificationClass II
Recall ReasonPursuant 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.
Recalling FirmSunset Natural Products Inc.
Firm Address7345 SW 45th St
Miami, FL, United States 33155-4509
Inital Firm NotificationLetter
Code InfoAs 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 # 181014 Exp. Date 10/17
Report DateJanuary 4, 2017
Classification DateDecember 28, 2016
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