Food recall

Global Health Laboratories, LLC recall: UT-Fem FOR WOMEN, urinary tract SOLUTION, Dietary Supplement

Global Health Laboratories, LLC, of Amityville, NY, recalled UT-Fem FOR WOMEN, urinary tract SOLUTION, Dietary Supplement. The FDA's reason: “The finished dietary supplement product was manufactured with ingredients subsequently found to be contaminated with chloramphenicol, an antibiotic, at levels above 0.3 ppb. The supplier, Specialty...” 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 8, 2017

The recall

Company
Global Health Laboratories, LLC (Amityville, NY)
Reason, in FDA's words
“The finished dietary supplement product was manufactured with ingredients subsequently found to be contaminated with chloramphenicol, an antibiotic, at levels above 0.3 ppb. The supplier, Specialty Enzymes & Biotechnologies, recalled the raw materials and notified the recipients. Subsequent private laboratory testing of the finished product revealed levels of chloramphenicol above 0.3 ppb.”
Where it was sold
New York
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
66765

The product recalled

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

  • F-1105-2014 Class II

    UT-Fem FOR WOMEN, urinary tract SOLUTION, Dietary Supplement, 42 Vegetable Capsules, Product No. 110403, UPC 7 98304 24865 4 -- Manufactured for: Global Quality Health Inc.

    Codes: Lot Number 1256074

    Quantity: 1495 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 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.