Drug product
Gel Hand Sanitizer (Ethyl Alcohol 70%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-487-49), b) 118 mL (4 fl oz) bottles (NDC 47593-487-33), and c) 540 mL (18 fl oz) bottles (NDC47593-487-31) Ecolab, 370 Wabasha Street N, St. Paul, MN 55102.
D-1060-2019
Product summary
- Firm
- Ecolab Inc
- Event
- Event 82344
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 22 units b) 314 units c) 3511 units
- Official record key
drug-enforcement:D-1060-2019
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) HS091281, Exp. AUG 2020, b) HS091781, Exp. AUG 2020 and c) HS082881, HS083081, and HS090781, Exp. AUG 2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination