FDAClass IIIMarch 6, 2019

Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 recall

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

Why was Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

FG Lot 2018410057; Expiration Date 8/2020

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
Recalling firm
ProThera, Inc. dba SFI USA
Quantity
120 bottles
Distribution
One customer in KS.
Recall date
March 6, 2019
Classification
Class III
Status
Terminated
Agency
FDA (food)
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