Food recall

ProThera, Inc. dba SFI USA recall: Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 mg tablets

ProThera, Inc. dba SFI USA, of Reno, NV, recalled Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 mg tablets. The FDA's reason: “Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine.” The FDA classified it Class III: it is unlikely to cause harm. The company began the recall voluntarily on January 17, 2019, and the FDA first listed it in its Enforcement Report of March 6, 2019. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class III

It is unlikely to cause harm

Why

Labeling, packaging or manufacturing problems

Status

Terminated

Closed March 26, 2019

The recall

Company
ProThera, Inc. dba SFI USA (Reno, NV)
Reason, in FDA's words
“Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine.”
Where it was sold
One customer in KS.
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
82010

The product recalled

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

  • F-1101-2019 Class III

    Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 mg tablets; Packed in a 75 cc HDPE Bottle 60 Tablets UPC: 8 28054 17845 8; SKU: ML1

    Codes: FG Lot 2018410057; Expiration Date 8/2020

    Quantity: 120 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 March 6, 2019.

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.