LOW RISK
Terminated
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
Recalled by ProThera, Inc. dba SFI USA
Classification
Class III — Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws.
Reason for Recall
Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine.
Product Details
Product Quantity
120 bottles
Product Type
Food
Code Info
FG Lot 2018410057; Expiration Date 8/2020
Voluntary/Mandated
Voluntary: Firm initiated
Distribution & Geography
Distribution Pattern
One customer in KS.
Company Location
Reno, NV, 89521-5920
Timeline
Report Date
03/06/2019
Recall Initiated
01/17/2019
Classification Date
02/27/2019
Termination Date
03/26/2019
Source: U.S. Food & Drug Administration (FDA) — FDA Recalls
Last updated: August 29, 2026
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