F-0544-2016 Class II Terminated
FDA food recall F-0544-2016 was initiated by Sunset Natural Products Inc. on Oct 5, 2015 and is designated Class II. 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… The recall status is terminated (terminated Apr 10, 2017). Affected quantity: 100,000 capsules.
Recall Details
- Product Type
- Food
- Report Date
- Feb 24, 2016
- Initiation Date
- Oct 5, 2015
- Termination Date
- Apr 10, 2017
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 100,000 capsules
Product Description
Venocell, sold in bulk of 50,000 capsules.
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 manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
Distribution Pattern
FL and NV
Code Information
Lot # 160614 Exp. Date 06/17 and Lot # 490914 Exp. Date 10/17
Source
- Dataset
- openFDA food recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for F-0544-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 23, 2026