Wise Woman Herbals Kava Capsules, 450 mg Kava (Piper met. Root), Dosage: 1 capsule up to 3 times per day day at 450mg Ka
Summary
The FDA issued a Class II for Wise Woman Herbals Kava Capsules, 450 mg Kava (Piper met. Root), Dosage: 1 capsu 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-1346-2022
Action Date
2022-06-29
Status
Terminated
Category
food
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.
Lot/Code Info: 90KACA (90 indicates package size; KA indicates Kava; CA indicates capsule). Lots: 16754, 17157, and 17764-1. Best Used By for each lot: 10/22/21 (for 16754); 10/22/22 (for 17157); 1/26/24 (for 17764-1).
Quantity Affected: 1,213 units
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-1346-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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