F-0963-2017 Class II Terminated

Recalled by Sunset Natural Products Inc. — Miami, FL

FDA food recall F-0963-2017 was initiated by Sunset Natural Products Inc. on Oct 13, 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: 5,812 Jar's (195G per Jar).

Recall Details

Product Type
Food
Report Date
Jan 4, 2017
Initiation Date
Oct 13, 2015
Termination Date
Apr 10, 2017
Voluntary/Mandated
FDA Mandated
Product Quantity
5,812 Jar's (195G per Jar)

Product Description

Colageina Orange, (195 g per Jar)

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 manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.

Distribution Pattern

Products distributed to Florida, Nevada and the Dominican Republic

Code Information

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 # 271014 Exp. Date 10/17, Lot # 281014 Exp. Date 12/17, Lot # 291014 Exp. Date 03/18, Lot # 301014 Exp. Date 04/18, Lot # 311014 Exp. Date 05/18, Lot # 230615 Exp. Date 05/18, Lot # 301114 Exp. Date 11/17

Source

Dataset
openFDA food recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for F-0963-2017
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 23, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.