Sunset Natural Products Inc.
Recall F-0983-2017 · Miami, FL
Product
Alri, 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
380,000 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 lots and expiration dates: Lot # 690514 Exp. Date 06/17, Lot # 270814 Exp. Date 09/17, Lot # 111014 Exp. Date 11/17, Lot # 421214 Exp. Date 01/18, Lot # 320315 Exp. Date 05/18
Timeline
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