Readyprep Chg Cloth
FDA Recall NDC 53329-244
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 Readyprep Chg (NDC 53329-244). A significant event, classified as Class III, was initiated on May 14, 2021 by Medline Industries, Lp. The reported reason for this action was: "Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate."
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
Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.
May 14, 2021
Jun 16, 2021
231,936 packs
Recall Profile & Regulatory Data
Event ID
88005
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Medline Industries Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA and Isreal
Termination Date
Aug 07, 2024
Product Description
READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) Disposable Cloths, Non-Sterile, Single Use Only, Manufactured by Medline Industries, Inc., Northfield, IL 60093 USA. NDC: 53329-244-01
Batch or Lot Expiration Information
Lot# :: 19EEA027, Exp May 2021; 19GEA049, Exp August 2021; 19HEA044, Exp Sept 2021
Affected Packages Involved in this Recall
53329-244-01Product
53329-244-03Product
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.
