Food 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
F-1348-2022
Product summary
- Firm
- EarthLab Inc
- Event
- Event 90203
- Status
- Terminated
- Classification
- Class II
- Quantity
- 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
- Official record key
food-enforcement:F-1348-2022
Official wording
Reason: The microbial test result is found to be out of specification due to high yeast and mold counts.
Code information: 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).
Distribution pattern: nationwide
Derived failure modes
-
Microbial contamination
found to be out of specification due to high yeast and mold
-
Potency or specification failure
out of specification