Sodium Chloride Injection
FDA Recall NDC 0641-6144

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 0641-6144). A significant event, classified as Class II, was initiated on Dec 07, 2020 by Hikma Pharmaceuticals Usa Inc.. The reported reason for this action was: "Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial."

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-0169-2021TERMINATEDD-0101-2021TERMINATED

December 2020 Class II Recall: Failed pH Specifications

Recall Number
D-0169-2021
Class II Terminated
Reason for Recall
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
Initiated
Dec 07, 2020
Reported
Dec 23, 2020
Quantity
1,324,072 vials

Recall Profile & Regulatory Data

Event ID
86948
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hikma Pharmaceuticals USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Jul 18, 2023
Product Description
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, Vial NDC 0641-0497-17
Batch or Lot Expiration Information
Lot# : 048315 EXP 4/2021; 068320 EXP 6/2021; 128302 EXP 12/2021; 099349 EXP 9/2022.
Affected Packages Involved in this Recall
0641-0497-17Product
0641-0497-25Product
0641-6144-01Product
0641-6144-25Product

November 2020 Class II Recall: Failed pH Specifications

Recall Number
D-0101-2021
Class II Terminated
Reason for Recall
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
Initiated
Nov 03, 2020
Reported
Nov 25, 2020
Quantity
2,100,646 Vials

Recall Profile & Regulatory Data

Event ID
86685
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hikma Pharmaceuticals USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.
Termination Date
Nov 17, 2022
Product Description
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sterile diluent, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, a) Vial NDC 0641-0497-17, b) Carton of 25 vials NDC 0641-0497-25.
Batch or Lot Expiration Information
Lot# a) Vial
Lot# s: 078338 Exp. 7/2021; Lot 088391, Exp. 08/2021; 098340, Exp. 09/2021; 108325 Exp. 10/2021; 010018 Exp. 1/2023; b) Carton
Lot# : 068322, Exp. 06/2021.
Affected Packages Involved in this Recall
0641-0497-17Product
0641-0497-25Product
0641-6144-01Product
0641-6144-25Product

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.