Class IIITerminated in FDA datasetJan 17, 2019

Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 mg tablets; Packed in a 75 cc HDPE Bottle 60 Tablets

Recalling firm: ProThera, Inc. dba SFI USA

Why it was recalled

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

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ProductKlaire 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
UPC828054178458

FDA code information

FG Lot 2018410057; Expiration Date 8/2020

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Full FDA record and distribution details

Original product description

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

Extracted codes and context

TypeCode / valueContext
UPC828054178458 Fast Dissolving 1 mg tablets; Packed in a 75 cc HDPE Bottle 60 Tablets UPC: 8 28054 17845 8; SKU: ML1

Recall details

Recall number
F-1101-2019
Event ID
82010
FDA status
Terminated
Initiated
Jan 17, 2019
Reported
Mar 6, 2019
Classified
Feb 27, 2019
Terminated
Mar 26, 2019
Quantity
120 bottles
Location
Reno, NV, United States
Initiation type
Voluntary: Firm initiated
Notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Where it was distributed

One customer in KS.

FDA source record · F-1101-2019

Data updated September 16, 2026. View official FDA data ↗

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