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Class II

EarthLab Inc

Recall #F-1347-2022 · Initiated 2022-05-11

Product
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
Reason for recall
The microbial test result is found to be out of specification due to high yeast and mold counts.
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
Distribution
nationwide
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).
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Terminated
2023-05-22

Recalling firm

EarthLab Inc
185 N Mill St
Creswell, OR 97426-9888
United States

Recall classification

Remote probability of serious adverse health consequences, or temporary reversible consequences.

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