Food recall

Ancient Formulas Inc recall: Bulk tablet label

Ancient Formulas Inc, of Wichita, KS, recalled Bulk tablet label and 1 other product. The FDA's reason: “Product contains higher levels of niacin than claimed on label .” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on March 22, 2013, and the FDA first listed it in its Enforcement Report of August 21, 2013. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class II

It could cause temporary or minor harm

Why

Labeling, packaging or manufacturing problems

Status

Terminated

Closed August 12, 2013

The recall

Company
Ancient Formulas Inc (Wichita, KS)
Reason, in FDA's words
“Product contains higher levels of niacin than claimed on label .”
Where it was sold
The bulk tablets were distributed to MO where they were repackaged into bottles. There was no foreign/military/government distribution.
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
64764

The 2 products recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • F-1802-2013 Class II

    Bulk tablet label: Keytabs W.O. Glandulars (pink)

    Codes: Lot 103-0313

    Quantity: 51,000 bulk tablets

  • F-1803-2013 Class II

    KEYTABS (Without Iron, Copper or Glandulars), packaged in 180-tablet bottles, a product of The Key Company, St. Louis, MO.

    Codes: Lot YDBI, Exp. 03/2016

    Quantity: 124/180-tablet bottles

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of August 21, 2013.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.