Sodium Chloride Injection, Solution
FDA Recall NDC 0264-5804

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

Active & Historical Enforcement Reports

The FDA has identified 5 recorded enforcement report(s) associated with Sodium Chloride (NDC 0264-5804). 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
0264-5802-00Product
0264-5802-10Product
0264-5804-00Product
0061852531Product

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
0264-5802-00Product
0264-5802-10Product
0264-5804-00Product
0061858305Product
0061858306Product

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
0264-5802-00Product
0264-5802-10Product
0264-5804-00Product
0061786962Product
0061797767Product
0061797768Product
0061787769Product
0061797770Product
0061797771Product
0061797772Product
0061797773Product
0061797774Product
0061797775Product
0061797776Product
0061812946Product
0061812947Product
0061812948Product
0061812949Product
0061812950Product
0061816017Product
0061816018Product
0061816019Product
0061816020Product
0061816021Product
0061816358Product
0061816359Product
0061816361Product
0061816362Product
0061816363Product
0061816364Product
0061818516Product
0061818517Product
0061818518Product
0061821562Product
0061821563Product
0061821564Product
0061823709Product
0061823710Product
0061823711Product
0061823714Product
0061823715Product
0061823716Product
0061824770Product
0061824771Product
0061824772Product
0061824773Product
0061824774Product
0061824775Product
0061824776Product
0061824777Product
0061826486Product
0061826487Product
0061826488Product

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
0264-5802-00Product
0264-5802-10Product
0264-5804-00Product
0061794230Product
0061794232Product
0061797779Product
0061797780Product
0061797781Product
0061797783Product
0061797784Product
0061797785Product
0061797786Product
0061797787Product
0061797788Product
0061809680Product

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
0264-5802-00Product
0264-5802-10Product
0264-5804-00Product
0061832446Product

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.