FDA recall record
Hepasil, (various bulk amounts)
FDA classification. FDA Class I, II, and III are not the same as USDA FSIS classifications and are not a cross-agency safety score.
FDA listed a termination date of April 10, 2017. openFDA does not treat this as a live recall-status tracker.
Product described in an FDA recall
Hepasil, (various bulk amounts)
Reason
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 involved
Product descriptions are copied from the FDA recall record. They are not a current catalog and are not automatically matched to WhoMadeMyFood product pages.
Hepasil, (various bulk amounts)
Code information listed by FDA
" 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
Distribution and firm information
Recalling firm listed by FDA: Sunset Natural Products Inc.
Firm location listed by FDA: Miami, FL, United States
Distribution reported by FDA: Products distributed to Florida, Nevada and the Dominican Republic
Product quantity listed by FDA: 2,650,000 capsules
Source
Source: U.S. Food and Drug Administration (FDA), openFDA food enforcement reports.
Official FDA openFDA food enforcement record
Identifying an FDA recall record does not imply FDA endorsement of WhoMadeMyFood. Methodology.