Terminated Class II

Sunset Natural Products Inc.

Recall F-0974-2017 · Miami, FL

Product

Horny Goat Weed, 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

1,100,000

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 # 320414 Exp. Date 05/17, Lot # 590614 Exp. Date 07/17, Lot # 510814 Exp. Date 09/17, Lot # 210914 Exp. Date 09/17, Lot # 540914 Exp. Date 10/17, Lot # 570914 Exp. Date 10/17, Lot # 151014 Exp. Date 11/17, Lot # 350215 Exp. Date 03/18, Lot # 350415 Exp. Date 05/18, Lot # 020115 Exp. Date 01/18

Timeline

13 Oct 2015 initiated 28 Dec 2016 classified 4 Jan 2017 reported 10 Apr 2017 terminated

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