Sunset Natural Products Inc. Recall 74054
Description: Oxy Extreme, 90 capsules per bottle
Sunset Natural Products Inc. Recall 74054 Information
Recall Status | Terminated |
Recall Event ID | 74054 |
Recall Number | F-0915-2017 |
Recall Date | October 13, 2015 |
Distribution | Products distributed to Florida, Nevada and the Dominican Republic |
Quantity | 1,200 bottles (108,000 capsules) |
Recall Mandatory? | FDA Mandated |
Product Type | Food |
Food Classification | Class II |
Recall Reason | 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. |
Recalling Firm | Sunset Natural Products Inc. |
Firm Address | 7345 SW 45th St Miami, FL, United States 33155-4509 |
Inital Firm Notification | Letter |
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 # 181014 Exp. Date 10/17 |
Report Date | January 4, 2017 |
Classification Date | December 28, 2016 |
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