Recalls / Class II

Class IIF-0934-2017

Product

Hepasil, (various bulk amounts)

Type

Food

Affected 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

Quantity

2,650,000 capsules

Why it was recalled

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.

Recalling firm

Firm

Sunset Natural Products Inc.

Notification channel

Letter

Type

FDA Mandated

Address

7345 SW 45th St, N/A, Miami, Florida 33155-4509

Distribution

Distribution pattern

Products distributed to Florida, Nevada and the Dominican Republic

Timeline

Recall initiated

2015-10-13

FDA classified

2016-12-28

Posted by FDA

2017-01-04

Terminated

2017-04-10

Status

Terminated

Source: openFDA Food Enforcement endpoint. Recall record F-0934-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings.