FDA recall record

EarthLab Wise Woman Herbals Kava Capsules, 450 mg Kava recall — FDA F-1346-2022

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

Class IIclassification
F-1346-2022official record ID
Jun 29, 2022report date

Recall record at a glance

Official recordF-1346-2022
CategoryFood Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmEarthLab Inc.
Report dateJun 29, 2022
Recall initiation dateMay 11, 2022
Quantity1,213 units
LocationCreswell, OR, United States

Official product description

Wise Woman Herbals Kava Capsules, 450 mg Kava (Piper met. Root), Dosage: 1 capsule up to 3 times per day day at 450mg Kava root. 90 counts per bottle. UPC 7 48840 14284 8. Kava Capsules older lots are packaged in 250cc Wide Mouth Amber Glass Packer, Black 45/400 PP ribbed skirt screw-top lid, clear neck band, Wise Woman Herbals Large botanical label. Kava Capsules newer lots are packaged in White polypropylene packer style bottle, White serrated flat-topped lid with foam liner, clear neckband, Wise Woman Herbals label.

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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