Scrub-stat Solution
FDA Recall NDC 47593-468
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 Scrub-stat (NDC 47593-468). A significant event, classified as Class III, was initiated on Feb 12, 2016 by Ecolab Inc.. The reported reason for this action was: "Subpotent drug"
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 III Terminated
Subpotent drug
Feb 12, 2016
Mar 16, 2016
706 bottles
Recall Profile & Regulatory Data
Event ID
73264
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Ecolab Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Puerto Rico and Canada
Termination Date
Mar 24, 2017
Product Description
Scrub-Stat 4 (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in a) 800 mL Plastic (HDPE) Bottles (NDC 47593-265-36), b) 1250 mL Plastic (HDPE) Bottles (NDC 47593-468-59), OTC, Ecolab, St Paul, MN 55102
Batch or Lot Expiration Information
Lot# : a) L041051, Exp 04 /17; L060151, L061951, Exp 06 /17; b) L060151, L061951, Exp 06 /17
Affected Packages Involved in this Recall
47593-468-41Product
47593-468-59Product
47593-468-44Product
47593-468-21Product
47593-468-36Product
47593-265-36Product
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.
