Drug product
Advanced Gel Hand Sanitizer (Ethyl alcohol 62%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-488-49) and b) 540 mL (18 fl oz) bottles (NDC 47593-488-31) Ecolab, 370 Wabasha Street N, St. Paul, MN 55102.
D-1061-2019
Product summary
- Firm
- Ecolab Inc
- Event
- Event 82344
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 118 units, b) 3,783 units
- Official record key
drug-enforcement:D-1061-2019
Official wording
Reason: Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Code information: Lot #: a) HS092781, Exp. SEP 2020; b) HS091381, HS091781, and HS091881, Exp. SEP 2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination