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Recall Observatory FDA recall evidence

Food 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

F-1101-2019

January 17, 2019

Class III

Product summary

Firm
ProThera, Inc. dba SFI USA
Event
Event 82010
Status
Terminated
Classification
Class III
Quantity
120 bottles
Official record key
food-enforcement:F-1101-2019

Official wording

Reason: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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