Baxter Healthcare Corp.
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.
Status:Ongoing
City:Deerfield
State:IL
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Letter
Distribution Pattern:Nationwide
Classification:Class I
Product Quantity:189,120 bags
Reason For Recall:Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Recall Initiation Date:20150717
Report Date:20150826
B. Braun Medical Inc
Product Description:0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB Container, Catalog No. S8004-5384, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1800-31
Status:Ongoing
City:Irvine
State:CA
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Letter
Distribution Pattern:Nationwide, Puerto Rico and Spain
Classification:Class I
Product Quantity:53,592 units
Reason For Recall:Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Recall Initiation Date:20131121
Report Date:20140507
Hospira Inc.
Product Description:0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-25.
Status:Ongoing
City:Lake Forest
State:IL
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern:Nationwide.
Classification:Class I
Product Quantity:9,912 VisIV flex containers
Reason For Recall:Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution.
Recall Initiation Date:20150305
Report Date:20150513
Hospira Inc.
Product Description:0.9% Sodium Chloride Injection, USP, 250 mL, Rx Only, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-7983-02
Status:Ongoing
City:Lake Forest
State:IL
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Press Release
Distribution Pattern:Nationwide
Classification:Class I
Product Quantity:661,128 containers
Reason For Recall:Presence of Particulate Matter; Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area.
Recall Initiation Date:20150120
Report Date:20150429
Baxter Healthcare Corp.
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.
Status:Ongoing
City:Deerfield
State:IL
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Letter
Distribution Pattern:Nationwide
Classification:Class I
Product Quantity:133,600 bags
Reason For Recall:Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Recall Initiation Date:20150717
Report Date:20150826

Sodium Chloride

Sodium Chloride

Sodium Chloride Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

Hypersensitivity/infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus have been reported with 0.9% Sodium Chloride Injection, USP.

Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing. Appropriate therapeutic countermeasures must be instituted as clinically indicated.

Depending on the volume and rate of infusion, the intravenous administration of Sodium Chloride Injection, USP can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration/hypervolemia, congested states, pulmonary edema, or acid-base imbalance. The risk of dilutive states is inversely proportional to the electrolyte concentration of the injection. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injection.

Monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation.

Administer 0.9% Sodium Chloride Injection, USP with particular caution, to patients with or at risk for hypernatremia, hyperchloremia, or metabolic acidosis.

Administer Sodium Chloride Injection, USP with particular caution, to patients with or at risk for hypervolemia or with conditions that may cause sodium retention, fluid overload and edema; such as patients with primary hyperaldosteronism, or secondary hyperaldosteronism [e.g., associated with hypertension, congestive heart failure, liver disease (including cirrhosis), renal disease (including renal artery stenosis, nephrosclerosis) or pre-eclampsia]. Certain medications may increase risk of sodium and fluid retention, see Drug Interactions.

Administer Sodium Chloride Injection, USP with particular caution, to patients with severe renal impairment. In such patients, administration of Sodium Chloride Injection, USP may result in sodium retention.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.

0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures.

History

There is currently no drug history available for this drug.

Other Information

Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The nominal pH is 5.0 (4.5 to 7.0). Composition, osmolarity, and ionic concentration are shown below:

0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride.

VIAFLO is a flexible plastic container fabricated from a multilayer sheeting (PL-2442) composed of Polypropylene (PP), Polyamide (PA) and Polyethylene (PE). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Two different administration connectors are available with VIAFLO containers. The VIAFLO dripless access container (DAC) will not drip once the spike is removed. The non-DAC VIAFLO will drip once the spike is removed from the administration port.

Sodium Chloride Manufacturers


  • Baxter Healthcare Corporation
    Sodium Chloride Injection, Solution [Baxter Healthcare Corporation]
  • Taro Pharmaceuticals U.s.a., Inc.
    Sodium Chloride (Sodium Chloride) Injection, Solution [Taro Pharmaceuticals U.s.a., Inc.]
  • Mckesson Packaging Services Business Unit Of Mckesson Corporation
    Sodium Chloride Injection [Mckesson Packaging Services Business Unit Of Mckesson Corporation]
  • Hospira, Inc.
    Sodium Chloride Injection, Solution [Hospira, Inc.]
  • Hospira, Inc.
    Sodium Chloride Injection, Solution [Hospira, Inc.]
  • General Injectables & Vaccines, Inc
    Sodium Chloride Injection, Solution, Concentrate [General Injectables & Vaccines, Inc]
  • Medefil, Inc.
    Sodium Chloride Injection, Solution [Medefil, Inc.]
  • General Injectables & Vaccines, Inc
    Sodium Chloride Injection, Solution [General Injectables & Vaccines, Inc]
  • Physicians Total Care, Inc.
    Sodium Chloride Injection [Physicians Total Care, Inc.]
  • Physicians Total Care, Inc.
    Sodium Chloride Injection, Solution [Physicians Total Care, Inc.]
  • West-ward Pharmaceutical Corp.
    Sodium Chloride Injection [West-ward Pharmaceutical Corp.]
  • West-ward Pharmaceutical Corp.
    Sodium Chloride Injection [West-ward Pharmaceutical Corp.]
  • Baxter Healthcare Corporation
    Sodium Chloride Injection, Solution [Baxter Healthcare Corporation]
  • B. Braun Medical Inc.
    Sodium Chloride Injection, Solution [B. Braun Medical Inc.]
  • App Pharmaceuticals, Llc
    Sodium Chloride Injection, Solution [App Pharmaceuticals, Llc]
  • App Pharmaceuticals, Llc
    Sodium Chloride Injection [App Pharmaceuticals, Llc]
  • App Pharmaceuticals, Llc
    Sodium Chloride Injection [App Pharmaceuticals, Llc]
  • App Pharmaceuticals, Llc
    Sodium Chloride Injection [App Pharmaceuticals, Llc]
  • App Pharmaceuticals, Llc
    Sodium Chloride Injection, Solution [App Pharmaceuticals, Llc]
  • Hospira, Inc.
    Sodium Chloride Injection, Solution [Hospira, Inc.]
  • Remedyrepack Inc.
    Sodium Chloride Injection, Solution [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Sodium Chloride Injection, Solution [Remedyrepack Inc. ]
  • Cardinal Health
    Sodium Chloride Injection [Cardinal Health]
  • Cardinal Health
    Sodium Chloride Injection [Cardinal Health]
  • Remedyrepack Inc.
    Sodium Chloride Injection [Remedyrepack Inc. ]
  • Cardinal Health
    Sodium Chloride Injection, Solution [Cardinal Health]
  • Baxter Healthcare Corporation
    Sodium Chloride Injection, Solution [Baxter Healthcare Corporation]
  • Baxter Healthcare Corporation
    Sodium Chloride Injection, Solution [Baxter Healthcare Corporation]
  • Cardinal Health
    Sodium Chloride Injection [Cardinal Health]
  • Mylan Pharmaceuticals Inc.
    Sodium Chloride [Mylan Pharmaceuticals Inc.]
  • Remedyrepack Inc.
    Sodium Chloride Injection, Solution [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Sodium Chloride Injection, Solution [Remedyrepack Inc. ]
  • American Regent, Inc.
    Sodium Chloride Injection, Solution [American Regent, Inc.]
  • Cardinal Health
    Sodium Chloride Injection, Solution [Cardinal Health]
  • Cardinal Health
    Sodium Chloride Injection, Solution [Cardinal Health]
  • Cardinal Health
    Sodium Chloride Injection, Solution [Cardinal Health]
  • B. Braun Medical Inc.
    Sodium Chloride Injection, Solution [B. Braun Medical Inc.]
  • B. Braun Medical Inc.
    Sodium Chloride Injection, Solution [B. Braun Medical Inc.]
  • Fresenius Kabi Usa, Llc
    Sodium Chloride Injection, Solution [Fresenius Kabi Usa, Llc]
  • Hospira, Inc.
    Sodium Chloride Injection, Solution [Hospira, Inc.]
  • B. Braun Medical Inc.
    Sodium Chloride Injection, Solution [B. Braun Medical Inc.]
  • Hospira, Inc.
    Sodium Chloride Injection, Solution [Hospira, Inc.]
  • Hospira, Inc.
    Sodium Chloride Injection, Solution [Hospira, Inc.]
  • Hospira, Inc.
    Sodium Chloride Injection, Solution [Hospira, Inc.]
  • Baxter Healthcare Corporation
    Sodium Chloride Injection, Solution [Baxter Healthcare Corporation]
  • Hospira, Inc.
    Sodium Chloride Injection [Hospira, Inc.]
  • Fresenius Medical Care North America
    Sodium Chloride Injection [Fresenius Medical Care North America]
  • Fresenius Medical Care North America
    Sodium Chloride Injection [Fresenius Medical Care North America]
  • Hospira, Inc.
    Sodium Chloride Injection, Solution, Concentrate [Hospira, Inc.]
  • Us Medsource, Llc
    Sodium Chloride Injection, Solution [Us Medsource, Llc]
  • Hospira, Inc.
    Sodium Chloride Injection, Solution [Hospira, Inc.]
  • Baxter Healthcare Corporation
    Sodium Chloride Injection [Baxter Healthcare Corporation]
  • Us Medsource, Llc
    Sodium Chloride Injection [Us Medsource, Llc]
  • West-ward Pharmaceutical Corp.
    Sodium Chloride Injection [West-ward Pharmaceutical Corp.]
  • Nephron Pharmaceuticals Corporation
    Sodium Chloride () Sodium Chloride () Solution Sodium Chloride () Solution [Nephron Pharmaceuticals Corporation]
  • Nephron Pharmaceuticals Corporation
    Sodium Chloride () Sodium Chloride () [Nephron Pharmaceuticals Corporation]
  • Mallinckrodt Inc.
    Sodium Chloride Injection [Mallinckrodt Inc.]
  • B. Braun Medical Inc.
    Sodium Chloride Injection [B. Braun Medical Inc.]
  • Hospira, Inc.
    Sodium Chloride Injection, Solution [Hospira, Inc.]

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