Drug product
Koala Hand Sanitizer, Menthol, 16 FL OZ., Antibacterial, (Ethyl Alcohol 69%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665
D-1358-2020
Product summary
- Event
- Event 85784
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1358-2020
Official wording
Reason: Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Code information: Lot #: 40920, Exp. Date 4/9/23; 41320, Exp. Date 4/13/23; 41420, Exp, Date 4/14/23; 41620, Exp. Date 4/16/23; 41720, 41720-2, Exp. Date 4/17/23
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Subpotent