FDA recall F-1101-2019

ProThera, Inc. dba SFI USA · Class III · 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

Reason for recall

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

Distribution

One customer in KS.

Key facts

Status
Terminated
Initiation date
2019-01-17
Report date
2019-03-06
Termination date
2019-03-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Reno, NV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-1101-2019