FDA Recall United States Terminated Historical recordClass II
ProThera, Inc. dba SFI USA
- Product
- Klaire Labs Reduced L-Glutathione 150 mg capsules, single…
- Published
- April 3, 2019
- Distribution
- US distribution to the following: AL, AZ…
ProThera, Inc. dba SFI USA Recall: Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine.
United States
TerminatedClass III
- Company
- ProThera, Inc. dba SFI USA
- Product
- Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 mg…
- Recall date
- January 17, 2019
- Terminated
- March 26, 2019
- Source
- FDA
Reason for recall
Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine.
- - Recall initiated
- - Reported by source
- - Recall terminated
| Product description | UPC | Quantity | Lot / code information |
|---|---|---|---|
| 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 | Not published in this source record | 120 bottles | FG Lot 2018410057; Expiration Date 8/2020 |
Distribution
- One customer in KS.
Official source record
- Agency
- FDA
- Dataset
- FDA Food Enforcement (Recalls)
- Recall number
- F-1101-2019
- Event ID
- 82010
- Status
- Terminated
- Classification
- Class III
- Company
- ProThera, Inc. dba SFI USA
- Product description
- 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
- Quantity
- 120 bottles
- Reason
- Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine.
- Recall initiation date
- January 17, 2019
- Report date
- March 6, 2019
- Classification date
- Not published in this source record
- Termination date
- March 26, 2019
- Distribution pattern
- One customer in KS.
- UPC, lot, and code information
- FG Lot 2018410057; Expiration Date 8/2020
- Voluntary or mandated
- Voluntary: Firm initiated
- Initial notification method
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Source last updated
- Not tracked separately from the Public Health Trace retrieval date below
- Public Health Trace retrieval date
Responsible company: ProThera, Inc. dba SFI USA
Other recalls from ProThera, Inc. dba SFI USA
A map highlighting the states named in the source's distribution description.
Shading reflects state-level totals only, as published by the source. It does not imply county-level or point-level precision.
| State | Distributed |
|---|---|
| Kansas | 1 |
States shown are extracted from the source's free-text distribution description above; a narrative description (e.g. "distributed nationwide") may not list individual states to extract.
Where this information comes from
View FDA enforcement record -- the specific openFDA record this summary was built from.
No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Technical source data
View raw source data -- the machine-readable record this page's information was built from.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class III mean?
A situation in which use of or exposure to a product is not likely to cause adverse health consequences.
Is this recall still active?
According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this product?
Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.
Where can I find more official information?
The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.
This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.
