Sodium Chloride Injection, Solution
FDA Recall NDC 0338-0049

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 16 recorded enforcement report(s) associated with Sodium Chloride (NDC 0338-0049). A significant event, classified as Class II, was initiated on Jul 18, 2019 by Baxter Healthcare Corporation. The reported reason for this action was: "Lack of Assurance of Sterility: Bags have potential to leak."

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

D-1514-2019TERMINATEDD-1190-2018TERMINATEDD-1128-2018TERMINATEDD-0957-2017TERMINATEDD-0973-2017TERMINATEDD-0957-2016TERMINATEDD-1816-2015TERMINATEDD-1336-2015TERMINATEDD-1326-2015TERMINATEDD-1208-2015TERMINATEDD-0425-2015TERMINATEDD-0429-2015TERMINATEDD-1583-2014TERMINATEDD-1591-2014TERMINATEDD-1163-2014TERMINATEDD-628-2013TERMINATED

July 2019 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-1514-2019
Class II Terminated
Reason for Recall
Lack of Assurance of Sterility: Bags have potential to leak.
Initiated
Jul 18, 2019
Reported
Jul 31, 2019
Quantity
139,680 Containers

Recall Profile & Regulatory Data

Event ID
83340
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the United States and Puerto Rico.
Termination Date
Apr 19, 2021
Product Description
0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38.
Batch or Lot Expiration Information
Lot# s: P389684; P389742, Exp. 8/31/2020
Affected Packages Involved in this Recall
0338-0049-01Product
0338-0049-02Product
0338-0049-03Product
0338-0049-04Product
0338-0049-10Product
0338-0049-41Product
0338-0049-11Product
0338-0049-31Product
0338-0049-48Product
0338-0049-18Product
0338-0049-38Product
0338-0043-03Product
0338-0043-04Product

September 2018 Class II Recall: cGMP Deviation

Recall Number
D-1190-2018
Class II Terminated
Reason for Recall
cGMP Deviation
Initiated
Sep 06, 2018
Reported
Sep 26, 2018
Quantity
5184 bags

Recall Profile & Regulatory Data

Event ID
80976
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Oct 01, 2020
Product Description
0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -- NDC 0338-0049-31
Batch or Lot Expiration Information
Lot# Lot: P380063 Exp. 12/2019
Affected Packages Involved in this Recall
0338-0049-01Product
0338-0049-02Product
0338-0049-03Product
0338-0049-04Product
0338-0049-10Product
0338-0049-41Product
0338-0049-11Product
0338-0049-31Product
0338-0049-48Product
0338-0049-18Product
0338-0049-38Product
0338-0043-03Product
0338-0043-04Product

August 2018 Class II Recall: CGMP Deviations

Recall Number
D-1128-2018
Class II Terminated
Reason for Recall
CGMP Deviations
Initiated
Aug 21, 2018
Reported
Sep 05, 2018
Quantity
33600 bags

Recall Profile & Regulatory Data

Event ID
80881
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
TX and MS only
Termination Date
Oct 30, 2019
Product Description
0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338-0049-18
Batch or Lot Expiration Information
Lot# : P380287, Exp. date 12/2019
Affected Packages Involved in this Recall
0338-0049-01Product
0338-0049-02Product
0338-0049-03Product
0338-0049-04Product
0338-0049-10Product
0338-0049-41Product
0338-0049-11Product
0338-0049-31Product
0338-0049-48Product
0338-0049-18Product
0338-0049-38Product
0338-0043-03Product
0338-0043-04Product

July 2017 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0957-2017
Class II Terminated
Reason for Recall
Lack of Assurance of Sterility: Customer complaints for leaking bags.
Initiated
Jul 06, 2017
Reported
Jul 19, 2017
Quantity
131,904 bags

Recall Profile & Regulatory Data

Event ID
77678
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in USA
Termination Date
Apr 29, 2020
Product Description
0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Distributed in Canada by Baxter Corporation, Toronto, Ontario, Canada, Product Code: 2B1322, NDC 0338-0049-02.
Batch or Lot Expiration Information
Lot# Lot: Y229153, Exp 09/30/18
Affected Packages Involved in this Recall
0338-0049-01Product
0338-0049-02Product
0338-0049-03Product
0338-0049-04Product
0338-0049-10Product
0338-0049-41Product
0338-0049-11Product
0338-0049-31Product
0338-0049-48Product
0338-0049-18Product
0338-0049-38Product
0338-0043-03Product
0338-0043-04Product

July 2017 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0973-2017
Class II Terminated
Reason for Recall
Lack of Assurance of Sterility: Bags have the potential to leak.
Initiated
Jul 06, 2017
Reported
Jul 19, 2017
Quantity
295,200 bags

Recall Profile & Regulatory Data

Event ID
77676
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Puerto Rico and Saudi Arabia
Termination Date
Apr 29, 2020
Product Description
0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B1309, NDC: 0338-0049-38
Batch or Lot Expiration Information
Lot# Lots: P361501, P361667, and P361790, Exp 09/30/18
Affected Packages Involved in this Recall
0338-0049-01Product
0338-0049-02Product
0338-0049-03Product
0338-0049-04Product
0338-0049-10Product
0338-0049-41Product
0338-0049-11Product
0338-0049-31Product
0338-0049-48Product
0338-0049-18Product
0338-0049-38Product
0338-0043-03Product
0338-0043-04Product

December 2015 Class I Recall: Presence of Particulate Matter

Recall Number
D-0957-2016
Class I Terminated
Reason for Recall
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Initiated
Dec 15, 2015
Reported
Jun 15, 2016
Quantity
255,852 VIAFLEX Plastic Containers

Recall Profile & Regulatory Data

Event ID
72816
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Apr 15, 2022
Product Description
0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0049-02
Batch or Lot Expiration Information
Lot# C980227; Exp. 11/16
Affected Packages Involved in this Recall
0338-0049-01Product
0338-0049-02Product
0338-0049-03Product
0338-0049-04Product
0338-0049-10Product
0338-0049-41Product
0338-0049-11Product
0338-0049-31Product
0338-0049-48Product
0338-0049-18Product
0338-0049-38Product
0338-0043-03Product
0338-0043-04Product

September 2015 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-1816-2015
Class II Terminated
Reason for Recall
Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch.
Initiated
Sep 02, 2015
Reported
Sep 30, 2015
Quantity
139,104 Bags

Recall Profile & Regulatory Data

Event ID
72060
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Sep 15, 2016
Product Description
0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38
Batch or Lot Expiration Information
Lot# : P329821, Exp 08/31/2016
Affected Packages Involved in this Recall
0338-0049-01Product
0338-0049-02Product
0338-0049-03Product
0338-0049-04Product
0338-0049-10Product
0338-0049-41Product
0338-0049-11Product
0338-0049-31Product
0338-0049-48Product
0338-0049-18Product
0338-0049-38Product
0338-0043-03Product
0338-0043-04Product

July 2015 Class I Recall: Presence of Particulate Matter

Recall Number
D-1336-2015
Class I Terminated
Reason for Recall
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Initiated
Jul 17, 2015
Reported
Aug 26, 2015
Quantity
189,120 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, 50 mL Single Dose VIAFLEX Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B1301, NDC 0338-0049-11.
Batch or Lot Expiration Information
Lot# : P319921, Exp 12/15
Affected Packages Involved in this Recall
0338-0049-01Product
0338-0049-02Product
0338-0049-03Product
0338-0049-04Product
0338-0049-10Product
0338-0049-41Product
0338-0049-11Product
0338-0049-31Product
0338-0049-48Product
0338-0049-18Product
0338-0049-38Product
0338-0043-03Product
0338-0043-04Product

July 2015 Class II Recall: Presence of Particulate Matter and Lack of Assurance of Sterility

Recall Number
D-1326-2015
Class II Terminated
Reason for Recall
Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors.
Initiated
Jul 02, 2015
Reported
Aug 19, 2015
Quantity
189,912 containers

Recall Profile & Regulatory Data

Event ID
71627
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
TX and TN
Termination Date
May 26, 2016
Product Description
0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0049-03.
Batch or Lot Expiration Information
Lot# : C964601, Exp 4/30/2016
Affected Packages Involved in this Recall
0338-0049-01Product
0338-0049-02Product
0338-0049-03Product
0338-0049-04Product
0338-0049-10Product
0338-0049-41Product
0338-0049-11Product
0338-0049-31Product
0338-0049-48Product
0338-0049-18Product
0338-0049-38Product
0338-0043-03Product
0338-0043-04Product

March 2015 Class I Recall: Presence of Particulate Matter

Recall Number
D-1208-2015
Class I Terminated
Reason for Recall
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Initiated
Mar 24, 2015
Reported
Jul 15, 2015
Quantity
202,824 Bags

Recall Profile & Regulatory Data

Event ID
70926
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US, Puerto Rico, and Bermuda
Termination Date
Feb 07, 2017
Product Description
0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0049-02
Batch or Lot Expiration Information
Lot# : C965038, C965293, C963785, C963884, C963660, C964320, C964486 and C964890, Exp 7/31/2016
Affected Packages Involved in this Recall
0338-0049-01Product
0338-0049-02Product
0338-0049-03Product
0338-0049-04Product
0338-0049-10Product
0338-0049-41Product
0338-0049-11Product
0338-0049-31Product
0338-0049-48Product
0338-0049-18Product
0338-0049-38Product
0338-0043-03Product
0338-0043-04Product

March 2015 Class II Recall: Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.

Recall Number
D-0425-2015
Class II Terminated
Reason for Recall
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Initiated
Mar 18, 2015
Reported
Apr 01, 2015
Quantity
597,498 units total

Recall Profile & Regulatory Data

Event ID
70770
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 24, 2016
Product Description
0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0049-03
Batch or Lot Expiration Information
Lot# : C929844, Exp 5/31/2015; C926873, Exp 4/30/2015; C928630, Exp 4/30/2015.
Affected Packages Involved in this Recall
0338-0049-01Product
0338-0049-02Product
0338-0049-03Product
0338-0049-04Product
0338-0049-10Product
0338-0049-41Product
0338-0049-11Product
0338-0049-31Product
0338-0049-48Product
0338-0049-18Product
0338-0049-38Product
0338-0043-03Product
0338-0043-04Product

March 2015 Class II Recall: Lack of Assurance of Sterility; increased complaints received for leaks

Recall Number
D-0429-2015
Class II Terminated
Reason for Recall
Lack of Assurance of Sterility; increased complaints received for leaks
Initiated
Mar 23, 2015
Reported
Apr 08, 2015
Quantity
196,128 containers

Recall Profile & Regulatory Data

Event ID
70695
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Singapore
Termination Date
Oct 20, 2016
Product Description
0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare Corporation, Deerfield, IL , Product code 2B1308, NDC 0338-0049-31
Batch or Lot Expiration Information
Lot# Product code: 2B1308
Lot# : P316497, exp date: 10/2015
Affected Packages Involved in this Recall
0338-0049-01Product
0338-0049-02Product
0338-0049-03Product
0338-0049-04Product
0338-0049-10Product
0338-0049-41Product
0338-0049-11Product
0338-0049-31Product
0338-0049-48Product
0338-0049-18Product
0338-0049-38Product
0338-0043-03Product
0338-0043-04Product

July 2014 Class II Recall: Lack of Assurance of Sterility; complaints of mold in the overpouch

Recall Number
D-1583-2014
Class II Terminated
Reason for Recall
Lack of Assurance of Sterility; complaints of mold in the overpouch
Initiated
Jul 30, 2014
Reported
Sep 17, 2014
Quantity
157,080 containers

Recall Profile & Regulatory Data

Event ID
69144
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jun 08, 2016
Product Description
0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-0049-03
Batch or Lot Expiration Information
Lot# C926642, Product Code: 2B1323N
Affected Packages Involved in this Recall
0338-0049-01Product
0338-0049-02Product
0338-0049-03Product
0338-0049-04Product
0338-0049-10Product
0338-0049-41Product
0338-0049-11Product
0338-0049-31Product
0338-0049-48Product
0338-0049-18Product
0338-0049-38Product
0338-0043-03Product
0338-0043-04Product

July 2014 Class I Recall: Presence of Particulate Matter

Recall Number
D-1591-2014
Class I Terminated
Reason for Recall
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Initiated
Jul 11, 2014
Reported
Sep 24, 2014
Quantity
a) 217,536 bags; b) 161,760 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, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIAFLEX Container bags, NDC 0338-0049-18, Product Code 2B1302, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
Batch or Lot Expiration Information
Lot# : a) P309187, Exp 10/14; b) P298190, Exp 08/14
Affected Packages Involved in this Recall
0338-0049-01Product
0338-0049-02Product
0338-0049-03Product
0338-0049-04Product
0338-0049-10Product
0338-0049-41Product
0338-0049-11Product
0338-0049-31Product
0338-0049-48Product
0338-0049-18Product
0338-0049-38Product
0338-0043-03Product
0338-0043-04Product

November 2013 Class I Recall: Presence of Particulate Matter

Recall Number
D-1163-2014
Class I Terminated
Reason for Recall
Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag
Initiated
Nov 21, 2013
Reported
Mar 26, 2014
Quantity
716,544 containers

Recall Profile & Regulatory Data

Event ID
67092
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Puerto Rico, Singapore, Saudi Arabia and United Arab Emirates.
Termination Date
Sep 21, 2016
Product Description
0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic containers (Product code 2B1308, NDC 0338-0049-31) and b) 100 mL Single dose VIAFLEX plastic containers (Product code 2B1302, NDC 0338-0049-18) and (Product code 2B1309, NDC 0338-0049-38), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
Batch or Lot Expiration Information
Lot# : a) P297283, Exp 08/14; b) P292326, Exp 04/14; P293993, Exp 05/14; and P293514, Exp 04/14
Affected Packages Involved in this Recall
0338-0049-01Product
0338-0049-02Product
0338-0049-03Product
0338-0049-04Product
0338-0049-10Product
0338-0049-41Product
0338-0049-11Product
0338-0049-31Product
0338-0049-48Product
0338-0049-18Product
0338-0049-38Product
0338-0043-03Product
0338-0043-04Product

May 2013 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-628-2013
Class II Terminated
Reason for Recall
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.
Initiated
May 21, 2013
Reported
Jul 10, 2013
Quantity
1,788,292 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
Sodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Container Quad Pack (NDC 0338-0049-11); b) 2B1302- 100mL in Viaflex Quad Pack (NDC 0338-0049-18); c) 2B1306- 50 mL in Viaflex Single Pack (NDC 0338-0049-41; d) 2B1307- 100mL in Viaflex Single Pack (NDC 0338-0049-48); e) 2B1308- 50 ML in Viaflex Multi Pack (NDC 0338-0049-31); f) 2B1309- 100mL in Viaflex Multi Pack (NDC 0338-0049-38), Rx Only, Baxter, Deerfield, IL 60015
Batch or Lot Expiration Information
Lot# : a) Product code 2B1301: P279943, P280370, Exp 7/13; b) Product code 2B1302: P280248, P280248A, P280248B, P285346, P285791, Exp 8/13; c) Product code 2B1306: P285601, Exp 5/13; d) Product code 2B1307: P280347, Exp 8/13; e) Product code 2B1308: P280404, P280404A, P285635, P285858, Exp 11/13; e) Product code 2B1309: P280149, Exp 8/13
Affected Packages Involved in this Recall
0338-0049-01Product
0338-0049-02Product
0338-0049-03Product
0338-0049-04Product
0338-0049-10Product
0338-0049-41Product
0338-0049-11Product
0338-0049-31Product
0338-0049-48Product
0338-0049-18Product
0338-0049-38Product
0338-0043-03Product
0338-0043-04Product

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.