Recalls / Class II
Class IID-0275-2019
Product
Medi-Stat Foam, Antimicrobial Hand Soap, Chloroxylenol 0.5%, 1250 mL (42.3 fl oz), OTC, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102, NDC 47593-503-59
- Brand name
- Ecolab Inc.
- Generic name
- Chloroxylenol
- Active ingredient
- Chloroxylenol
- Route
- Topical
- NDC
- 47593-503
- FDA application
- 505G(a)(3)
- Affected lot / code info
- Lot#: L062281, Exp 06/20
Why it was recalled
Labeling: Label mix-up - the label on the product may not match the formula in the bottle.
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
- 14,108 bottles
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2018-11-09
- FDA classified
- 2018-11-20
- Posted by FDA
- 2018-11-28
- Terminated
- 2020-11-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0275-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.