# FDA recall F-1101-2019

> **ProThera, Inc. dba SFI USA** · Class III · food recall initiated 2019-01-17.

## 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

- **Recall number:** F-1101-2019
- **Recalling firm:** ProThera, Inc. dba SFI USA
- **Classification:** Class III
- **Product type:** food
- **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

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

## Citation

> AI Analytics. FDA recall F-1101-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/F-1101-2019. Source: US FDA. Licensed CC0.

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