Recalls / Class II
Class IIF-0959-2017
Product
Colageina Gold, 195 g Jars
- 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 # 230514 Exp. Date 06/17, Lot # 330614 Exp. Date 06/17, Lot # 500714 Exp. Date 09/17, Lot # 510714 Exp. Date 10/17, Lot # 520714 Exp. Date 11/17, Lot # 360914 Exp. Date 07/18, Lot # 430814 Exp. Date 08/16, Lot # 450814 Exp. Date 08/14, Lot # 330914 Exp. Date 09/16, Lot # 340914 Exp. Date 09/16, Lot # 350914 Exp. Date 09/16, Lot # 370914 Exp. Date 09/16
- Quantity
- 10,663 Jars
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-0959-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings.