FDA recall record

EarthLab Wise Woman Herbals Standardized Kava Glycerite, product is recall — FDA F-1347-2022

The microbial test result is found to be out of specification due to high yeast and mold counts.

Class IIclassification
F-1347-2022official record ID
Jun 29, 2022report date

Recall record at a glance

Official recordF-1347-2022
CategoryFood Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmEarthLab Inc.
Report dateJun 29, 2022
Recall initiation dateMay 11, 2022
Quantity2 fl oz = 704 units; 4 fl oz = 262 units; 8 fl oz = 65 units; 16 fl oz = 30 units; 32 fl oz = 1 unit
LocationCreswell, OR, United States

Official 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

Why the product was recalled

The microbial test result is found to be out of specification due to high yeast and mold counts.

Distribution information

nationwide

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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