FDA Recall United States Terminated Historical recordClass III
ProThera, Inc. dba SFI USA
- Product
- Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 mg…
- Published
- March 6, 2019
- Distribution
- One customer in KS.
ProThera, Inc. dba SFI USA Recall: Mis-packaging; product is labeled as Reduce L-Glutathione but actually contains Lithium Orotate.
United States
TerminatedClass II
- Company
- ProThera, Inc. dba SFI USA
- Product
- Klaire Labs Reduced L-Glutathione 150 mg capsules, single…
- Recall date
- December 13, 2018
- Terminated
- April 2, 2019
- Source
- FDA
Reason for recall
Mis-packaging; product is labeled as Reduce L-Glutathione but actually contains Lithium Orotate.
- - Recall initiated
- - Reported by source
- - Recall terminated
| Product description | UPC | Quantity | Lot / code information |
|---|---|---|---|
| Klaire Labs Reduced L-Glutathione 150 mg capsules, single capsule dose 100 vegetarian capsules SKU V799-10 UPC Code: 7 09616 79910 9 | Not published in this source record | 139 bottles | FG Lot: 2018210303 Expiration: 05/2020 |
Distribution
- US distribution to the following: AL
- AZ
- CA
- KS
- LA
- MI
- MO
- NH
- NJ
- NY
- OR
- PA
- TX
- and WA Foreign distribution to the following: Netherlands
- Great Britain
- and Korea
Official source record
- Agency
- FDA
- Dataset
- FDA Food Enforcement (Recalls)
- Recall number
- F-1186-2019
- Event ID
- 81788
- Status
- Terminated
- Classification
- Class II
- Company
- ProThera, Inc. dba SFI USA
- Product description
- Klaire Labs Reduced L-Glutathione 150 mg capsules, single capsule dose 100 vegetarian capsules SKU V799-10 UPC Code: 7 09616 79910 9
- Quantity
- 139 bottles
- Reason
- Mis-packaging; product is labeled as Reduce L-Glutathione but actually contains Lithium Orotate.
- Recall initiation date
- December 13, 2018
- Report date
- April 3, 2019
- Classification date
- Not published in this source record
- Termination date
- April 2, 2019
- Distribution pattern
- US distribution to the following: AL, AZ, CA, KS, LA, MI, MO, NH, NJ, NY, OR, PA, TX, and WA Foreign distribution to the following: Netherlands, Great Britain, and Korea
- UPC, lot, and code information
- FG Lot: 2018210303 Expiration: 05/2020
- Voluntary or mandated
- Voluntary: Firm initiated
- Initial notification method
- Letter
- 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 |
|---|---|
| Alabama | 1 |
| Arizona | 1 |
| California | 1 |
| Kansas | 1 |
| Louisiana | 1 |
| Michigan | 1 |
| Missouri | 1 |
| New Hampshire | 1 |
| New Jersey | 1 |
| New York | 1 |
| Oregon | 1 |
| Pennsylvania | 1 |
| Texas | 1 |
| Washington | 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 II mean?
A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.
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.
