FDA recall F-1346-2022

Product

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.

Reason for recall

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

Distribution

nationwide

Key facts

Status

Terminated

Initiation date

2022-05-11

Report date

2022-06-29

Termination date

2023-05-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Creswell, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-1346-2022