Exact FDA event identifier

Event 82010

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: January 17, 2019
Product types: Food
Classifications: Class III
Statuses: Terminated
Recalling firm wording: ProThera, Inc. dba SFI USA

Dossier provenance

Source snapshots represented here

openFDA Food Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

food · product 1 of 1

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

F-1101-2019

Recall number: F-1101-2019
Initiated: January 17, 2019
Classification: Class III
Status: Terminated
Recalling firm: ProThera, Inc. dba SFI USA
Quantity: 120 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

FG Lot 2018410057; Expiration Date 8/2020

Distribution pattern

One customer in KS.