Sunset Natural Products Inc.

Recall #F-0934-2017 · Initiated 2015-10-13

Product

Hepasil, (various bulk amounts)

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

2,650,000 capsules

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 # 400414 Exp. Date 04/17, Lot # 070514 Exp. Date 05/17, Lot # 100614 Exp. Date 06/17, Lot # 110614 Exp. Date 06/17, Lot # 120614 Exp. Date 06/17, Lot # 130614 Exp. Date 06/17, Lot # 140614 Exp. Date 06/17, Lot # 150614 Exp. Date 06/17, Lot # 130515 Exp. Date 03/18, Lot # 190515 Exp. Date 05/18

Voluntary / mandated

FDA Mandated

Initial notification

Letter

Terminated

2017-04-10