Wise Woman Herbals Standardized Kava Glycerite, product is liquid and contains 15 mg Kavalactones (from Piper methysticu
Summary
The FDA issued a Class II for Wise Woman Herbals Standardized Kava Glycerite, product is liquid and contains 1 by EarthLab Inc. Reason: The microbial test result is found to be out of specification due to high yeast and mold counts..
Details
Source
Food Recall
External ID
F-1347-2022
Action Date
2022-06-29
Status
Terminated
Category
food
Product Description
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
Lot/Code Info: 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).
Quantity Affected: 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
Reason for Recall
The microbial test result is found to be out of specification due to high yeast and mold counts.
Distribution
nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-11
Company
Creswell, OR
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 78 food recalls issued in the same week, part of 204 food-related FDA actions this month.
EarthLab Inc has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (EarthLab Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does EarthLab Inc have FDA actions?
EarthLab Inc has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-1347-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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