Home / Sunset Natural Products Inc. / F-0537-2016
Class II
Sunset Natural Products Inc.
Recall #F-0537-2016 · Initiated 2015-10-05
Product
Argindione, sold as bulk of 50,000 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 manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
Quantity affected
100,000 capsules
Distribution
FL and NV
Lot / code info
Lot # 480514 Exp. Date 05/17 and Lot # 320614 Exp. Date 06/17
Voluntary / mandated
FDA Mandated
Initial notification
Other
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.