Food Recall Check
Class III · Low risk Terminated Initiated Jan 17, 2019 (8 years ago)

Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 mg tablets recall

Recalled by ProThera, Inc. dba SFI USA · Reno, NV, United States

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine.

A label that does not match the product can hide an ingredient someone must avoid, or show a wrong use-by date. All labeling errors recalls.

What was recalled

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

Quantity: 120 bottles

Food: Dietary supplements

Lot codes, dates and UPCs

A recall covers only these codes. Compare them with the lot number, best-by date or UPC printed on your package.

FG Lot 2018410057; Expiration Date 8/2020

Where it was sold

Kansas

FDA's distribution note: One customer in KS.

Low risk, but check. Class III means the product is unlikely to make anyone ill but breaks an FDA rule, often a labeling one. If your package matches, the store will normally refund it. FDA lists this recall as terminated: the company has finished removing the product, so it should no longer be on shelves - but it can still be in a freezer or pantry.

Recalling firm
ProThera, Inc. dba SFI USA
Initiated by
Voluntary: Firm initiated
Recall initiated
Jan 17, 2019
In FDA report of
Mar 6, 2019
Terminated
Mar 26, 2019
FDA recall number
F-1101-2019 · event 82010
Official record
FDA enforcement report search

Other recalls by ProThera, Inc. dba SFI USA

Class II · Moderate risk Terminated Other

Pro Thera Dual Detox Dietary Supplement

Reason Firm was notified by supplier of the enzyme Xylanase that it was contaminated with chloramphenicol.

ProThera, Inc. F-0180-2014

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