Coclss, bulk capsules
Recalling firm: Sunset Natural Products Inc.
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…
Historical recall record. This is not a new recall announcement. “Terminated” describes the FDA recall process; it does not certify that an individual package is safe. FDA termination date: Apr 10, 2017.
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FDA 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 # 090414 Exp. Date 05/17, Lot # 100414 Exp. Date 05/17, Lot # 110414 Exp. Date 05/17, Lot # 040115 Exp. Date 01/18, Lot # 160315 Exp. Date 04/18, Lot # 190615 Exp. Date 07/18, Lot # 200615 Exp. Date 07/18
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Full FDA record and distribution details
Original product description
Coclss, bulk capsules
Extracted codes and context
| Type | Code / value | Context |
|---|---|---|
| lot | 040115 | Date 05/17, Lot # 100414 Exp. Date 05/17, Lot # 110414 Exp. Date 05/17, Lot # 040115 Exp. Date 01/18, Lot # 160315 Exp. Date 04/18, Lot # 190615 Exp. Date 07/18, Lot # 200615 Exp. Date 07/18 |
| lot | 090414 | ee was entered on September 25, 2015. Known lots and expiration dates: Lot # 090414 Exp. Date 05/17, Lot # 100414 Exp. Date 05/17, Lot # 110414 Exp. Date 05/17, Lot # 040115 Exp. Date 01/18, Lot # 1603 |
| lot | 100414 | , 2015. Known lots and expiration dates: Lot # 090414 Exp. Date 05/17, Lot # 100414 Exp. Date 05/17, Lot # 110414 Exp. Date 05/17, Lot # 040115 Exp. Date 01/18, Lot # 160315 Exp. Date 04/18, Lot # 1906 |
| lot | 110414 | ation dates: Lot # 090414 Exp. Date 05/17, Lot # 100414 Exp. Date 05/17, Lot # 110414 Exp. Date 05/17, Lot # 040115 Exp. Date 01/18, Lot # 160315 Exp. Date 04/18, Lot # 190615 Exp. Date 07/18, Lot # 2006 |
| lot | 160315 | Date 05/17, Lot # 110414 Exp. Date 05/17, Lot # 040115 Exp. Date 01/18, Lot # 160315 Exp. Date 04/18, Lot # 190615 Exp. Date 07/18, Lot # 200615 Exp. Date 07/18 |
| lot | 190615 | Date 05/17, Lot # 040115 Exp. Date 01/18, Lot # 160315 Exp. Date 04/18, Lot # 190615 Exp. Date 07/18, Lot # 200615 Exp. Date 07/18 |
| lot | 200615 | Date 01/18, Lot # 160315 Exp. Date 04/18, Lot # 190615 Exp. Date 07/18, Lot # 200615 Exp. Date 07/18 |
Original FDA recall reason
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.
Recall details
- Recall number
- F-0968-2017
- Event ID
- 74054
- FDA status
- Terminated
- Initiated
- Oct 13, 2015
- Reported
- Jan 4, 2017
- Classified
- Dec 28, 2016
- Terminated
- Apr 10, 2017
- Quantity
- 2,400,000 capsules
- Location
- Miami, FL, United States
- Initiation type
- FDA Mandated
- Notification
- Letter
Where it was distributed
Products distributed to Florida, Nevada and the Dominican Republic
Data updated September 16, 2026. View official FDA data ↗
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