FDA recall D-0361-2021

Spartan Chemical Co Inc · Class II · drug

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

Reason for recall

CGMP Deviations

Distribution

Nationwide USA and Puerto Rico; Mexico

Key facts

Status
Terminated
Initiation date
2021-03-29
Report date
2021-04-21
Termination date
2023-10-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Maumee, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0361-2021