Hidroxol Dietary Supplement (unknown container size)
Sunset Natural Products Inc. recalled this product and the FDA reported the enforcement action on 4 January 2017 as Class II. The recall was mandated. 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.
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
- Product
- Hidroxol Dietary Supplement (unknown container size)
- 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.
- Recalling firm
- Sunset Natural Products Inc.
- Firm location
- Miami, Florida, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1029-2017
- Quantity
- Unknown
- Distribution
- Products distributed to Florida, Nevada and the Dominican Republic
- Initiated
- 13 October 2015
- Reported by FDA
- 4 January 2017
- Terminated
- 10 April 2017
- Firm notified by
- Letter
- Product codes
- 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 lot: Lot # 410614, 020814, 150914, 260914, 181214, 210115, 330115, 150215, 540315, 200415, 530615, 010715
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
- This recall was not recorded as firm-initiated. The circumstances in which the FDA requests a recall are set out in 21 CFR 7.45.
- This is one of 163 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 163 separate recalls, which almost every published figure does, overstates it by a factor of 163. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 163 of them.
- The recall ran for 18 months, from 13 October 2015 to termination on 10 April 2017. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
- The FDA published the enforcement report 15 months after the firm began the recall.
- Recalls of a dietary supplement run a median of 15 months, so this one was about typical for its category. Dietary supplements are regulated under their own good manufacturing practice rule, 21 CFR part 111, and they are the only food category where the dominant recall reason is an ingredient that was never declared because it is a pharmaceutical.
Filed under dietary supplements. A product can sit in more than one.
Other dietary supplements recalls
These are the closest records in the corpus: the same kind of food. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
Other records from Sunset Natural Products Inc.
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 172 other records name this firm.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2017-01-04 | Colon Therapy, bulk capsules | 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 that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations. | Class II |
| 2017-01-04 | DHEA 25 mg, bulk capsules | 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 that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations. | Class II |
| 2017-01-04 | Oyster Dietary Supplement (unknown container size) | 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 that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations. | Class II |
| 2017-01-04 | Liver Energy, 100 capsules per bottle | 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 that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations. | Class II |
| 2017-01-04 | Arganine & Pine Bark, bulk capsules | 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 that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations. | Class II |
| 2017-01-04 | Esclewe Dietary Supplement (unknown container size) | 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 that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations. | Class II |
| 2017-01-04 | Chromium Picolinate Dietary Supplement (unknown container size) | 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 that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations. | Class II |
| 2017-01-04 | Sugar Burner Dietary Supplement (unknown container size) | 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 that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations. | Class II |
| 2017-01-04 | Strev, bulk capsules | 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 that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations. | Class II |
| 2017-01-04 | Equs Mas, (30 capsules per bottle) | 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 that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations. | Class II |
All 173 records for Sunset Natural Products Inc.
All 2017 recalls · All FDA food recall data
Behind every recall is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.