Sodium Chloride Injection, Solution
FDA Recall NDC 0264-5802

Latest: Class III · Status: Terminated · Initiated Aug 02, 2023 · 5 enforcement reports

Active & Historical Enforcement Reports

The FDA has identified 5 recorded enforcement report(s) associated with Sodium Chloride (NDC 0264-5802). A significant event, classified as Class III, was initiated on Aug 02, 2023 by B. Braun Medical Inc.. The reported reason for this action was: "Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed."

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-1083-2023TERMINATEDD-0916-2023TERMINATEDD-0346-2023COMPLETEDD-0347-2023COMPLETEDD-0076-2023TERMINATED

August 2023 Class III Recall: Labeling

Recall Number
D-1083-2023
Class III Terminated
Reason for Recall
Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
Initiated
Aug 02, 2023
Reported
Aug 16, 2023
Quantity
43,812 bags

Recall Profile & Regulatory Data

Event ID
92797
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
B. Braun Medical Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States
Termination Date
Jul 07, 2025
Product Description
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
Batch or Lot Expiration Information
Lot# : 0061852531, Exp 2/28/2025
Affected Packages Involved in this Recall
0264-5802-00Sodium Chloride
0264-5802-10Sodium Chloride
0264-5804-00Sodium Chloride
0061852531Sodium Chloride

July 2023 Class II Recall: Lack of assurance of sterility

Recall Number
D-0916-2023
Class II Terminated
Reason for Recall
Lack of assurance of sterility: bags have the potential to leak.
Initiated
Jul 05, 2023
Reported
Jul 19, 2023
Quantity
79,880 bags

Recall Profile & Regulatory Data

Event ID
92640
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
B. Braun Medical Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Apr 23, 2024
Product Description
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00
Batch or Lot Expiration Information
Lot# : 0061858305, 0061858306 Exp 3/31/2025
Affected Packages Involved in this Recall
0264-5802-00Sodium Chloride
0264-5802-10Sodium Chloride
0264-5804-00Sodium Chloride
0061858305Sodium Chloride
0061858306Sodium Chloride

February 2023 Class II Recall: Lack of sterility assurance

Recall Number
D-0346-2023
Class II Completed
Reason for Recall
Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.
Initiated
Feb 10, 2023
Reported
Mar 01, 2023
Quantity
1,343,982 bags

Recall Profile & Regulatory Data

Event ID
91658
Classification
Class II
Enforcement Status
Completed
Recalling Firm
B. Braun Medical Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide.
Product Description
0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
Batch or Lot Expiration Information
Lot# Lots: 0061786962 Exp. 11/30/2023; 0061797767 Exp. 04/30/2024; 0061797768 Exp. 05/31/2024; 0061787769 Exp. 05/31/2024; 0061797770 Exp. 05/31/2024; 0061797771 Exp. 05/31/2024; 0061797772 Exp. 05/31/2024; 0061797773 Exp. 05/31/2024; 0061797774 Exp. 05/31/2024; 0061797775 Exp. 05/31/2024; 0061797776 Exp. 05/31/2024; 0061812946 Exp. 05/31/2024; 0061812947 Exp. 05/31/2024; 0061812948 Exp. 05/31/2024; 0061812949 Exp. 05/31/2024; 0061812950 Exp. 05/31/2024; 0061816017 Exp. 06/30/2024; 0061816018 Exp. 06/30/2024; 0061816019 Exp. 06/30/2024; 0061816020 Exp. 06/30/2024; 0061816021 Exp. 06/30/2024; 0061816358 Exp. 06/30/2024; 0061816359 Exp. 06/30/2024; 0061816361 Exp. 07/31/2024; 0061816362 Exp. 07/31/2024; 0061816363 Exp. 07/31/2024; 0061816364 Exp. 07/31/2024; 0061818516 Exp. 07/31/2024; 0061818517 Exp. 07/31/2024; 0061818518 Exp. 07/31/2024; 0061821562 Exp. 08/31/2024; 0061821563 Exp. 08/31/2024; 0061821564 Exp. 08/31/2024; 0061823709 Exp. 08/31/2024; 0061823710 Exp. 08/31/2024; 0061823711 Exp. 08/31/2024; 0061823714 Exp. 08/31/2024; 0061823715 Exp. 08/31/2024; 0061823716 Exp. 08/31/2024; 0061824770 Exp. 08/31/2024; 0061824771 Exp. 08/31/2024; 0061824772 Exp. 08/31/2024; 0061824773 Exp. 08/31/2024; 0061824774 Exp. 08/31/2024; 0061824775 Exp. 08/31/2024; 0061824776 Exp. 08/31/2024; 0061824777 Exp. 08/31/2024; 0061826486 Exp. 08/31/2024; 0061826487 Exp. 08/31/2024; 0061826488 Exp. 08/31/2024
Affected Packages Involved in this Recall
0264-5802-00Sodium Chloride
0264-5802-10Sodium Chloride
0264-5804-00Sodium Chloride
0061786962Sodium Chloride
0061797767Sodium Chloride
0061797768Sodium Chloride
0061787769Sodium Chloride
0061797770Sodium Chloride
0061797771Sodium Chloride
0061797772Sodium Chloride
0061797773Sodium Chloride
0061797774Sodium Chloride
0061797775Sodium Chloride
0061797776Sodium Chloride
0061812946Sodium Chloride
0061812947Sodium Chloride
0061812948Sodium Chloride
0061812949Sodium Chloride
0061812950Sodium Chloride
0061816017Sodium Chloride
0061816018Sodium Chloride
0061816019Sodium Chloride
0061816020Sodium Chloride
0061816021Sodium Chloride
0061816358Sodium Chloride
0061816359Sodium Chloride
0061816361Sodium Chloride
0061816362Sodium Chloride
0061816363Sodium Chloride
0061816364Sodium Chloride
0061818516Sodium Chloride
0061818517Sodium Chloride
0061818518Sodium Chloride
0061821562Sodium Chloride
0061821563Sodium Chloride
0061821564Sodium Chloride
0061823709Sodium Chloride
0061823710Sodium Chloride
0061823711Sodium Chloride
0061823714Sodium Chloride
0061823715Sodium Chloride
0061823716Sodium Chloride
0061824770Sodium Chloride
0061824771Sodium Chloride
0061824772Sodium Chloride
0061824773Sodium Chloride
0061824774Sodium Chloride
0061824775Sodium Chloride
0061824776Sodium Chloride
0061824777Sodium Chloride
0061826486Sodium Chloride
0061826487Sodium Chloride
0061826488Sodium Chloride

February 2023 Class II Recall: Lack of sterility assurance

Recall Number
D-0347-2023
Class II Completed
Reason for Recall
Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.
Initiated
Feb 10, 2023
Reported
Mar 01, 2023
Quantity
483,229 bags

Recall Profile & Regulatory Data

Event ID
91658
Classification
Class II
Enforcement Status
Completed
Recalling Firm
B. Braun Medical Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide.
Product Description
0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10
Batch or Lot Expiration Information
Lot# Lots: 0061794230 Exp. 01/31/2024; 0061794232 Exp. 01/31/2024; 0061797779 Exp. 02/29/2024; 0061797780 Exp. 02/29/2024; 0061797781 Exp. 02/29/2024; 0061797783 Exp. 02/29/2024; 0061797784 Exp. 03/31/2024; 0061797785 Exp. 03/31/2024; 0061797786 Exp. 03/31/2024; 0061797787 Exp. 03/31/2024; 0061797788 Exp. 03/31/2024; 0061809680 Exp. 04/30/2024
Affected Packages Involved in this Recall
0264-5802-00Sodium Chloride
0264-5802-10Sodium Chloride
0264-5804-00Sodium Chloride
0061794230Sodium Chloride
0061794232Sodium Chloride
0061797779Sodium Chloride
0061797780Sodium Chloride
0061797781Sodium Chloride
0061797783Sodium Chloride
0061797784Sodium Chloride
0061797785Sodium Chloride
0061797786Sodium Chloride
0061797787Sodium Chloride
0061797788Sodium Chloride
0061809680Sodium Chloride

November 2022 Class II Recall: Lack of sterility assurance

Recall Number
D-0076-2023
Class II Terminated
Reason for Recall
Lack of sterility assurance: Bags have the potential to leak.
Initiated
Nov 25, 2022
Reported
Dec 14, 2022
Quantity
756 bags

Recall Profile & Regulatory Data

Event ID
91194
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
B. Braun Medical, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, NJ, PA
Termination Date
Aug 23, 2024
Product Description
0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862
Batch or Lot Expiration Information
Lot# Lot: 0061832446 Exp. 31 Oct 2024
Affected Packages Involved in this Recall
0264-5802-00Sodium Chloride
0264-5802-10Sodium Chloride
0264-5804-00Sodium Chloride
0061832446Sodium Chloride

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.