Lite Nfoamy Healthcare Personnel Handwash Soap
FDA Recall NDC 64009-335

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 Lite Nfoamy Healthcare Personnel Handwash (NDC 64009-335). A significant event, classified as Class II, was initiated on Mar 29, 2021 by Spartan Chemical Company. 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.

Reported Recall Events

March 2021 Class II Recall: CGMP Deviations

Recall Number
Class II Terminated
Reason for Recall
CGMP Deviations
Initiated
Mar 29, 2021
Reported
Apr 21, 2021
Quantity
960 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
Lite'n Foamy Healthcare Personnel Handwash (Chloroxylenol, 1.0%), Net Contents: 18 oz/ 532 ml per foam pump container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26283 0 NDC: 64009-335-82
Batch or Lot Expiration Information
Lot# Lot, expiry: Lot 538310, exp 1/21/2023
Affected Packages Involved in this Recall
64009-335-85Product
64009-335-82Product

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.