Class IIIFDA17 Jan 2019F-1101-2019

ProThera, Inc. dba SFI USA recalls Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 mg tablets; Packed in a 75 cc HDPE (Class III)

Class III — Eating this product is not likely to cause health problems, but it violates FDA labelling or manufacturing rules.

Product

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

Reason for recall

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

Affected products (1)

Recall #	Product	Lot / code	Status
F-1101-2019	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	FG Lot 2018410057; Expiration Date 8/2020	Terminated

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