Sodium Chloride Irrigant
FDA Recall NDC 0338-0048
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Sodium Chloride (NDC 0338-0048). A significant event, classified as Class II, was initiated on Feb 05, 2016 by Baxter Healthcare Corporation. The reported reason for this action was: "PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect."
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
PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect.
Feb 05, 2016
Mar 09, 2016
257,364 bottles
Recall Profile & Regulatory Data
Event ID
73235
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Nov 16, 2016
Product Description
0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product code 2F7123, NDC 0338-0048-03
Batch or Lot Expiration Information
Lot# G120162, Exp 11/18
Affected Packages Involved in this Recall
0338-0048-02Product
0338-0048-03Product
0338-0048-04Product
0338-0048-05Product
Class II Terminated
Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation.
Apr 21, 2014
May 07, 2014
211,752 bottles
Recall Profile & Regulatory Data
Event ID
67974
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
nationwide
Termination Date
Feb 24, 2015
Product Description
0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0048-04.
Batch or Lot Expiration Information
Lot# Gl09272; Exp 09/16
Affected Packages Involved in this Recall
0338-0048-02Product
0338-0048-03Product
0338-0048-04Product
0338-0048-05Product
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.
