Antiseptic Hand Cleaner Soap
FDA Recall NDC 64009-336
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Antiseptic Hand Cleaner (NDC 64009-336). A significant event, classified as Class II, was initiated on Mar 29, 2021 by Spartan Chemical Company, Inc.. The reported reason for this action was: "CGMP Deviations"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations
Mar 29, 2021
Apr 21, 2021
400 containers
Recall Profile & Regulatory Data
Event ID
87633
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Spartan Chemical Co Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA and Puerto Rico; Mexico
Termination Date
Oct 16, 2023
Product Description
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
Batch or Lot Expiration Information
Lot# Lot, expiry: Lot 538885, exp 1/25/2023
Affected Packages Involved in this Recall
64009-336-85Product
64009-336-90Product
64009-336-91Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
