Sunset Natural Products Inc.

Recall #F-0959-2017 · Initiated 2015-10-13

Product

Colageina Gold, 195 g Jars

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.

Quantity affected

10,663 Jars

Distribution

Products distributed to Florida, Nevada and the Dominican Republic

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 # 230514 Exp. Date 06/17, Lot # 330614 Exp. Date 06/17, Lot # 500714 Exp. Date 09/17, Lot # 510714 Exp. Date 10/17, Lot # 520714 Exp. Date 11/17, Lot # 360914 Exp. Date 07/18, Lot # 430814 Exp. Date 08/16, Lot # 450814 Exp. Date 08/14, Lot # 330914 Exp. Date 09/16, Lot # 340914 Exp. Date 09/16, Lot # 350914 Exp. Date 09/16, Lot # 370914 Exp. Date 09/16

Voluntary / mandated

FDA Mandated

Initial notification

Letter

Terminated

2017-04-10