Food recall: Bulk tablet label: Keytabs W.O. Glandulars (pink)
Class II FDA enforcement event 64764. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Product contains higher levels of niacin than claimed on label .
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
Ancient Formulas Inc started this food recall on 22 Mar 2013. The firm address in the FDA record is in Wichita, KS. FDA put the recall in Class II. FDA event 64764 has 2 product records. The first FDA enforcement report date is 21 Aug 2013. The record gives the status Terminated, with the termination date 12 Aug 2013.
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.
The bulk tablets were distributed to MO where they were repackaged into bottles. There was no foreign/military/government distribution.
Recalling firm
Ancient Formulas Inc, Wichita, KS.
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-1802-2013 | Bulk tablet label: Keytabs W.O. Glandulars (pink) | 51,000 bulk tablets | Class II | Terminated | 21 Aug 2013 |
| F-1803-2013 | KEYTABS (Without Iron, Copper or Glandulars), packaged in 180-tablet bottles, a product of The Key Company, St. Louis, MO. | 124/180-tablet bottles | Class II | Terminated | 21 Aug 2013 |
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 2013
- 546
- Share of these events in Class II
- 52%
- Product records in this event
- 2Median of the firm: 2
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 25 Jan 2024 | Healthprint Vitamin D3 5000 Dietary Supplement, 200 tablets, packaged in plastic bottle. Event 93899 | Food | Class III | 1 |
Official channels
- FDA enforcement report F-1802-2013The 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 64764. https://recallregister.com/fda/ii/64764/. 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:
The bulk tablets were distributed to MO where they were repackaged into bottles. There was no foreign/military/government distribution.
- What quantity of product is in FDA event 64764?
- The event has 2 product records. The first record gives this quantity:
51,000 bulk tablets
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many food recalls of 2013 have the same class?
- 52% of the 546 food events that started in 2013 are in Class II.