FDA Recall United States TerminatedTerminated: May 22, 2023Historical recordClass II
EarthLab Inc
- Product
- Wise Woman Herbals Sleepytime Glycerite. Product is liquid a…
- Published
- June 29, 2022
- Distribution
- Nationwide
United States
TerminatedClass II
The microbial test result is found to be out of specification due to high yeast and mold counts.
| Product description | UPC | Quantity | Lot / code information |
|---|---|---|---|
| Wise Woman Herbals Standardized Kava Glycerite, product is liquid and contains 15 mg Kavalactones (from Piper methysticum) and 9 mg Kavalactones (from Piper methysticum) depending on lot. Dosage: 60 drops 1-2 times a day. Product is packaged in Amber Glass Boston Round bottle, Black serrated polypropylene dropper assembly with rubber bulb (2oz only) or Black serrated phenolic lid with polypropylene cone insert (4oz and larger), Clear neck band, Wise Woman Herbals label. Each size has the following UPCs: 2 oz UPC 7 48840 14275 6 4 oz UPC 7 48840 14276 3 8 oz UPC 7 48840 14277 0 16 oz UPC 7 48840 14278 7 32 oz UPC 7 48840 14279 4 | Not published in this source record | 2 fl oz = 704 units; 4 fl oz = 262 units; 8 fl oz = 65 units; 16 fl oz = 30 units; 32 fl oz = 1 unit | 2PIGL, 4PIGL, 8PIGL, 16PIGL, 32PIGL. (1st digit indicates package size; PI indicates Piper, Latin name of Kava; GL indicates Glycerite). Lots: 17816, 17391, 16988, 16872, 16742. Best Used By for each lot: 9/10/23 (for 17816); 10/2/22 (for 17391); 10/24/21 (for 16988); 8/7/21 (for 16872); 4/25/21 (for 16742). |
This recall shares FDA event ID 90203 with 2 other product entries in Public Health Trace.
FDA Recall United States TerminatedTerminated: May 22, 2023Historical recordClass II
FDA Recall United States TerminatedTerminated: May 22, 2023Historical recordClass II
Responsible company: EarthLab Inc
FDA Recall United States TerminatedTerminated: May 22, 2023Historical recordClass II
FDA Recall United States TerminatedTerminated: May 22, 2023Historical recordClass II
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Retrieved by Public Health Trace:
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.
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.
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This record is preserved as published by FDA, as of May 22, 2023.
Status as reported: Terminated.
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