Food recall

Metagenics, Inc. recall: Spectrazyme

Metagenics, Inc., of Aliso Viejo, CA, recalled Spectrazyme. The FDA's reason: “Metagenics is recalling Spectrazyme because their raw material supplier informed them that enzymes in the blend may contain the antibiotic chloramphenicol.” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on October 11, 2013, and the FDA first listed it in its Enforcement Report of November 20, 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

See FDA's words below

Status

Terminated

Closed March 3, 2014

The recall

Company
Metagenics, Inc. (Aliso Viejo, CA)
Reason, in FDA's words
“Metagenics is recalling Spectrazyme because their raw material supplier informed them that enzymes in the blend may contain the antibiotic chloramphenicol.”
Where it was sold
Nationwide in US and worldwide to Japan, Taiwan, Belgium, and Canada
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
66511

The product recalled

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

  • F-0138-2014 Class II

    Spectrazyme, 180 count, 60 count, 12 bottles/case, 20000 tablets/box, 14000 capsules/pail.

    Codes: Lot Code: 0413083 0513007 0513008

    Quantity: 1,171,300 units

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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 November 20, 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.