Food recall

Global Health Laboratories, LLC recall: (a) ONEBODE Flo daily, probiotic enzyme digestive

Global Health Laboratories, LLC, of Amityville, NY, recalled (a) ONEBODE Flo daily, probiotic enzyme digestive. The FDA's reason: “The finished dietary supplement product was manufactured with ingredients found to be contaminated with chloramphenicol, an antibiotic, above levels of 0.3 ppb.” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on November 7, 2013, and the FDA first listed it in its Enforcement Report of December 25, 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 March 10, 2017

The recall

Company
Global Health Laboratories, LLC (Amityville, NY)
Reason, in FDA's words
“The finished dietary supplement product was manufactured with ingredients found to be contaminated with chloramphenicol, an antibiotic, above levels of 0.3 ppb.”
Where it was sold
Arizona
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
66766

The product recalled

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

  • F-1112-2014 Class II

    (a) ONEBODE Flo daily, probiotic enzyme digestive, 90 capsules, dietary supplement, Product No. T00135, UPC 0 14834 00135 5; (b) ONEBODE Flo for Family, probiotic enzyme digestive, 360 capsules, dietary supplement, Product No. T00109, UPC 0 14834 00109 6; (c) ONEBODE Flo daily, probiotic enzyme digestive, 6 capsules, dietary supplement (SAMPLE PACK), Product No. T00111, UPC 0 14834 00111 9 --- Mfg. for OneBode, Chandler, Arizona 85226

    Codes: (a) Lot Number 1262057; (b) Lot Number 1262058; (c) Lot Numbers 26813, 26813A, 26813B

    Quantity: Lot 1262057: 1985 bottles; Lot 1262058: 489 bottles; Sample packs: 11,276 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 December 25, 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.