Refresh Antibac Foam Soap
FDA Recall NDC 11084-010
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 Refresh Antibac Foam (NDC 11084-010). A significant event, classified as Class II, was initiated on Oct 26, 2018 by Sc Johnson Professional Usa Inc.. The reported reason for this action was: "CGMP Deviations: Product was released to market prior to microbiological testing."
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: Product was released to market prior to microbiological testing.
Oct 26, 2018
Nov 14, 2018
869 cases
Recall Profile & Regulatory Data
Event ID
81453
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
S.C. Johnson Professional
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
NC
Termination Date
Sep 08, 2020
Product Description
deb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Made in the USA, Deb USA, Inc., Charlotte, NC 28217, NDC 11084-010-27.
Batch or Lot Expiration Information
Lot# Lot 9131
Affected Packages Involved in this Recall
11084-010-40Product
11084-010-27Product
11084-010-12Product
11084-010-20Product
11084-010-05Product
11084-010-01Product
11084-010-55Product
11084-010-96Product
11084-010-66Product
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.
