Sodium Chloride Injection
FDA Recall NDC 0338-0553
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 7 recorded enforcement report(s) associated with Sodium Chloride (NDC 0338-0553). A significant event, classified as Class I, was initiated on Jan 21, 2016 by Baxter Healthcare Corporation. The reported reason for this action was: "Presence of Particulate Matter: identified as cardboard."
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 I Terminated
Presence of Particulate Matter: identified as cardboard.
Jan 21, 2016
Jun 01, 2016
273,520 bags
Recall Profile & Regulatory Data
Event ID
73118
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Feb 26, 2018
Product Description
0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.
Batch or Lot Expiration Information
Lot# : P328997, Exp 01/31/2016
Affected Packages Involved in this Recall
0338-0553-11Product
0338-0553-18Product
Class II Terminated
Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.
Jan 21, 2016
Jun 01, 2016
282,080 bags
Recall Profile & Regulatory Data
Event ID
73118
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Feb 26, 2018
Product Description
0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.
Batch or Lot Expiration Information
Lot# : P337857, Exp 07/31/16
Affected Packages Involved in this Recall
0338-0553-11Product
0338-0553-18Product
Class I Terminated
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Jul 17, 2015
Aug 26, 2015
133,600 bags
Recall Profile & Regulatory Data
Event ID
71749
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Dec 01, 2016
Product Description
0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.
Batch or Lot Expiration Information
Lot# : P327635, Exp 12/15
Affected Packages Involved in this Recall
0338-0553-11Product
0338-0553-18Product
Class I Terminated
Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
Dec 04, 2014
Apr 15, 2015
542,080 container bags
Recall Profile & Regulatory Data
Event ID
69962
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico.
Termination Date
Apr 14, 2017
Product Description
0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, Product Code 2B0043, NDC 0338-0553-18.
Batch or Lot Expiration Information
Lot# : P317891, P317842, Exp 05/15
Affected Packages Involved in this Recall
0338-0553-11Product
0338-0553-18Product
Class I Terminated
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Jul 11, 2014
Sep 24, 2014
390,560 bags
Recall Profile & Regulatory Data
Event ID
68728
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Puerto Rico, Singapore, and Hong Kong
Termination Date
Sep 21, 2016
Product Description
0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0553-18, Product Code 2B0043.
Batch or Lot Expiration Information
Lot# : P308650, Exp 10/14
Affected Packages Involved in this Recall
0338-0553-11Product
0338-0553-18Product
Class II Terminated
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
May 21, 2013
Jul 10, 2013
845,520 units
Recall Profile & Regulatory Data
Event ID
65288
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide & Puerto Rico
Termination Date
Jun 18, 2015
Product Description
0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (NDC 0338-0553-11), b) 100 mL (NDC 0338-0553-18), Rx Only, Baxter, Deerfield, IL 60015
Batch or Lot Expiration Information
Lot# : a) Product code 2B0042: P285668, P285668A, P285668C, P285734, Exp 5/13; b) Product code 2B0043: P285395, Exp 5/13
Affected Packages Involved in this Recall
0338-0553-11Product
0338-0553-18Product
February 2013 Class II Recall: Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL.
Recall Number
Class II Terminated
Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL.
Feb 27, 2013
Jul 03, 2013
317,280 bags
Recall Profile & Regulatory Data
Event ID
65061
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Singapore
Termination Date
May 11, 2015
Product Description
0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, distributed by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0553-11
Batch or Lot Expiration Information
Lot# Lot: P293118; Exp Date: 10/13
Affected Packages Involved in this Recall
0338-0553-11Product
0338-0553-18Product
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.
