Recalls / Class II
Class IID-0361-2021
Product
Antiseptic Hand Cleaner (Chloroxylenol, 1.0%), Net Contents: 1 US Gallon/ 3.79 Liters per gallon container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA.UPC 7 53727 26257 1 NDC: 64009-336-85
- Brand name
- Antiseptic Hand Cleaner
- Generic name
- Chloroxylenol
- Active ingredient
- Chloroxylenol
- Route
- Topical
- NDC
- 64009-336
- FDA application
- 505G(a)(3)
- Affected lot / code info
- Lot, expiry: Lot 538885, exp 1/25/2023
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Spartan Chemical Co Inc
- Manufacturer
- Spartan Chemical Company, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1110 Spartan Dr, N/A, Maumee, Ohio 43537-1725
Distribution
- Quantity
- 400 containers
- Distribution pattern
- Nationwide USA and Puerto Rico; Mexico
Timeline
- Recall initiated
- 2021-03-29
- FDA classified
- 2021-04-30
- Posted by FDA
- 2021-04-21
- Terminated
- 2023-10-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0361-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.