FDA Food Class II — Moderate

Lebytol, 30 capsules per bottle

Hazard

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.

Products

Lebytol, 30 capsules per bottle
Brand
Sunset Natural Products Inc.
UPC
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 # 210714 Exp. Date 07/17, Lot # 041214 Exp. Date 07/17, Lot # 030315 Exp. Date 03/18, Lot # 051114 Exp. Date 11/17, Lot # 301214 Exp. Date 12/17

Units Affected

2,400 Bottles, (72,000 capsules)