Food recall: Xambo, 80 boxes of bulk capsules. Each containing 12,053 capsules in each box.
Class II FDA enforcement event 76003. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
West Coast Laboratories is recalling Xambo and Devagrass because there may be presence of 1,3-dimethylamylamine (DMAA).
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
West Coast Laboratories Inc started this food recall on 11 Jan 2017. The firm address in the FDA record is in Gardena, CA. FDA put the recall in Class II. FDA event 76003 has 2 product records. The first FDA enforcement report date is 8 Feb 2017. The record gives the status Terminated, with the termination date 20 Mar 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.
Colombia, South America
Recalling firm
West Coast Laboratories Inc, Gardena, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| F-1430-2017 | Xambo, 80 boxes of bulk capsules. Each containing 12,053 capsules in each box. | 964,240 capsules | Class II | Terminated | 8 Feb 2017 |
| F-1431-2017 | Devagrass | 3,600 blisters | Class II | Terminated | 8 Feb 2017 |
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 2017
- 599
- Share of these events in Class II
- 52%
- Product records in this event
- 2
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report F-1430-2017The 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 76003. https://recallregister.com/fda/ii/76003/. 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:
Colombia, South America
- What quantity of product is in FDA event 76003?
- The event has 2 product records. The first record gives this quantity:
964,240 capsules
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many food recalls of 2017 have the same class?
- 52% of the 599 food events that started in 2017 are in Class II.