Drug recall
Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 mg tablets; Packed in a 75 cc HDPE Bottle 60 Tablets…
FDA recall event 82010 · Class III · ProThera, Inc. dba SFI USA
Key facts
| Event ID | 82010 |
|---|---|
| Recall numbers | F-1101-2019 |
| Recalling firm | ProThera, Inc. dba SFI USA |
| Product type | Food |
| Products | 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 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine. |
| Initiation date | Jan 17, 2019 |
| Report date | Mar 6, 2019 |
| Termination date | Mar 26, 2019 |
| City | Reno |
| State | NV |
| Country | United States |
| FEI number | 3003552448 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: