PlainRecalls
FDA Food Moderate Class II Terminated

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 14

Reported: June 29, 2022 Initiated: May 11, 2022 #F-1348-2022

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

Reason for Recall

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

Details

Recalling Firm
EarthLab Inc
Units 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
Distribution
nationwide
Location
Creswell, OR

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by EarthLab Inc. Units 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.
Why was this product recalled? ▼
The microbial test result is found to be out of specification due to high yeast and mold counts.
Which agency issued this recall? ▼
This recall was issued by the FDA Food on June 29, 2022. Severity: Moderate. Recall number: F-1348-2022.

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