Recalls / Class II
Class IID-1061-2019
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.
- Brand name
- Advanced Gel Hand Sanitizer
- Generic name
- Alcohol
- Active ingredient
- Alcohol
- Route
- Topical
- NDC
- 47593-488
- FDA application
- 505G(a)(3)
- Affected lot / code info
- Lot #: a) HS092781, Exp. SEP 2020; b) HS091381, HS091781, and HS091881, Exp. SEP 2020
Why it was recalled
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Recalling firm
- Firm
- Ecolab Inc
- Manufacturer
- Ecolab Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Level 7 370 N, N/A, Saint Paul, Minnesota 55102
Distribution
- Quantity
- a) 118 units, b) 3,783 units
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-02-06
- FDA classified
- 2019-03-27
- Posted by FDA
- 2019-04-03
- Terminated
- 2022-08-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1061-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.