Wise Woman Herbals Sleepytime Glycerite. Product is liquid and strength is 20% presence in formula. Dosage: 60 drops 1-4
Summary
The FDA issued a Class II for Wise Woman Herbals Sleepytime Glycerite. Product is liquid and strength is 20% p 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-1348-2022
Action Date
2022-06-29
Status
Terminated
Category
food
Product Description
Wise Woman Herbals Sleepytime Glycerite. Product is liquid and strength is 20% presence in formula. Dosage: 60 drops 1-4 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 14269 5 4 oz UPC 7 48840 14270 1 8 oz UPC 7 48840 14271 8 16 oz UPC 7 48840 14272 5 32 oz UPC 7 48840 14273 2
Lot/Code Info: 2SLGL, 4SLGL, 8SLGL, 16SLGL, 32SLGL. (1st digit indicates package size; SL indicates Sleepytime; GL indicates Glycerite). Lots: 17950, 17724, 17648, 17338, 17019, 16963, 16905. Best if Use for each lot: 10/19/23 (for lot 17950); 3/24/23 (for lot 17724); 3/2/23 (for lot 17648); 9/29/22 (for lot 17338); 11/25/21 (for lot 17019); 9/20/21 (for lot 16963); 8/14/21 (for lot 16905).
Quantity Affected: 1 fl oz = 1,010 units; 2 fl oz = 1,219 units; 4 fl oz = 282 units; 8 fl oz = 46 units; 16 fl oz = 16 units; 32 fl oz = 4 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-1348-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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