FDA recall F-1348-2022

Product

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.

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-1348-2022