Sunset Natural Products Inc.
Recall F-0994-2017 · Miami, FL
Product
DHEA 25 mg, bulk capsules
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
1,444,900 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 lots and expiration dates: Lot # 140714 Exp. Date 08/17, Lot # 310914 Exp. Date 10/17, Lot # 560914 Exp. Date 10/17, Lot # 271214 Exp. Date 12/17, Lot # 070115 Exp. Date 01/18, Lot # 460315 Exp. Date 04/18, Lot # 080615 Exp. Date 08/18
Timeline
Sourced directly from the FDA’s openFDA enforcement database. This information is for educational purposes only and does not constitute health or legal advice. FoodRecallFinder.com is not affiliated with or endorsed by the U.S. Food and Drug Administration.