Recalls / Class II
Class IIF-0617-2016
Product
Hepasil, sold in bulk of 500,000 capsules.
- Type
- Food
- Affected lot / code info
- Lot # 080315 Exp. Date 03/18
- Quantity
- 500,000 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 manufatured 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
- Other
- Type
- FDA Mandated
- Address
- 7345 SW 45th St, Miami, Florida 33155-4509
Distribution
- Distribution pattern
- FL and NV
Timeline
- Recall initiated
- 2015-10-05
- FDA classified
- 2016-02-17
- Posted by FDA
- 2016-02-24
- Terminated
- 2017-04-10
- Status
- Terminated
Source: openFDA Food Enforcement endpoint. Recall record F-0617-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings.