Food recall: Abee Med, 60 capsules per bottle. Manufactured by Sunset Natural Products
Class II FDA enforcement event 72877. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sunset Natural Products Inc. started this food recall on 5 Oct 2015. The firm address in the FDA record is in Miami, FL. FDA put the recall in Class II. FDA event 72877 has 10 product records. The first FDA enforcement report date is 24 Feb 2016. The record gives the status Terminated, with the termination date 10 Apr 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
FL and NV
Recalling firm
Sunset Natural Products Inc., Miami, FL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: FDA Mandated.
Products
10 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| F-0536-2016 | Abee Med, 60 capsules per bottle. Manufactured by Sunset Natural Products | 3,149 bottles (240,000 caps) | Class II | Terminated | 24 Feb 2016 |
| F-0537-2016 | Argindione, sold as bulk of 50,000 capsules. | 100,000 capsules | Class II | Terminated | 24 Feb 2016 |
| F-0538-2016 | Chardon de Marie, 60 capsules per bottle. Manufactured by Sunset Natural Products | 3,260 bottles (200,000 caps) | Class II | Terminated | 24 Feb 2016 |
| F-0539-2016 | Moinsage, 60 capsules per bottle. Manufactured by Sunset Natural Products | 5,000 bottles (300,000 caps) | Class II | Terminated | 24 Feb 2016 |
| F-0540-2016 | Neuro-Cetin, sold in bulk 50,000 capsules. | 50,000 capsules | Class II | Terminated | 24 Feb 2016 |
| F-0541-2016 | Prostaliv, 60 capsules per bottle. Manufactured by Sunset Natural Products | 5000 bottles (300,000) | Class II | Terminated | 24 Feb 2016 |
| F-0542-2016 | Prostamax DUO, 60 capsules per bottle. Manufactured by Sunset Natural Products | 4,000 bottles (240,000 capsules) | Class II | Terminated | 24 Feb 2016 |
| F-0543-2016 | Prostax Forte, sold in bulk of 50,000 capsules. | 50,000 capsules | Class II | Terminated | 24 Feb 2016 |
| F-0544-2016 | Venocell, sold in bulk of 50,000 capsules. | 100,000 capsules | Class II | Terminated | 24 Feb 2016 |
| F-0617-2016 | Hepasil, sold in bulk of 500,000 capsules. | 500,000 capsules | Class II | Terminated | 24 Feb 2016 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Food events that started in 2015
- 607
- Share of these events in Class II
- 46%
- Product records in this event
- 10Median of the firm: 163
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 13 Oct 2015 | Bionix, 30 capsules per bottle | Food | Class II | 163 |
Official channels
- FDA enforcement report F-0536-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA: report a problemThe FDA page that shows where a report about a product goes.
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Cite this page
Recall Register. FDA enforcement event 72877. https://recallregister.com/fda/ii/72877/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA food enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
FL and NV
- What quantity of product is in FDA event 72877?
- The event has 10 product records. The first record gives this quantity:
3,149 bottles (240,000 caps)
- How did the recall start?
- The FDA record says:
FDA Mandated
- How many food recalls of 2015 have the same class?
- 46% of the 607 food events that started in 2015 are in Class II.