Chlorhexidine Gluconate Rinse
FDA Recall NDC 0116-2001
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 0116-2001). A significant event, classified as Class II, was initiated on Jun 01, 2017 by Xttrium Laboratories, Inc.. 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.
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
Jun 01, 2017
Jul 12, 2017
36,720 16 oz. glass bottles
Recall Profile & Regulatory Data
Event ID
77443
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Xttrium Laboratories Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Natiowide
Termination Date
Feb 19, 2018
Product Description
Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only, Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056, NDC 0116-2001-16
Batch or Lot Expiration Information
Lot# 1999CHG16MC-Lot number 704-201 (full
Lot# 704-1999-201), Exp 03/20 1999CHG16MC-Lot number 705-208 (full
Lot# 705-1999-208), Exp 04/20
Affected Packages Involved in this Recall
0116-2001-16Product
0116-2001-04Product
0116-2001-15Product
0116-2001-05Product
0116-2001-06Product
0116-2001-07Product
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.
