Chlorhexidine Gluconate Cloth
FDA Recall NDC 53462-705
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 Chlorhexidine Gluconate (NDC 53462-705). A significant event, classified as Class II, was initiated on Jul 29, 2016 by Sage Products Llc. The reported reason for this action was: "CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product."
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: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Jul 29, 2016
Dec 28, 2016
2756 cases
Recall Profile & Regulatory Data
Event ID
74819
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sage Products LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.
Termination Date
Mar 11, 2019
Product Description
2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #9705, b) Reorder #9701-P, and c) Reorder #9780, Sage Products LLC 3909 Three Oaks Road, Cary, Illinois 60013, NDC 53462-705-20.
Batch or Lot Expiration Information
Lot# : a) 50749, Exp. 9/29/16; 50765, Exp. 9/30/16; 50771, Exp. 9/30/16; 50773, Exp. 10/01/16; 52839, Exp. 2/9/17; 52843, Exp. 2/9/17; 52855, Exp. 2/10/17; 52861, Exp. 2/10/17; 53840, Exp. 4/21/17; 56081, Exp. 9/1/17; 56513, Exp. 9/26/17; b) 54760, Exp. 6/15/17; c) 54763, Exp. 6/16/17 a)
Lot# 50749 , Exp. 9/29/2016
Lot# 50765 , Exp. 9/30/2016
Lot# 50771 , Exp. 9/30/2016
Lot# 50773 , Exp. 10/1/2016
Lot# 52839 , Exp. 2/9/2017
Lot# 52843 , Exp. 2/9/2017
Lot# 52855 , Exp. 2/10/2017
Lot# 52861 , Exp. 2/10/2017
Lot# 53840 , Exp. 4/21/2017 . b)
Lot# 54763, Exp. 6/16/2017. c)
Lot# 54760, Exp. 6/15/2017.
Affected Packages Involved in this Recall
53462-705-20Product
53462-705-23Product
53462-705-26Product
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.
