Label: SODIUM CHLORIDE injection

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Unapproved drug for use in drug shortage

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated August 19, 2014

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  • IMPORTANT PRESCRIBING INFORMATION

    B. Braun Medical Inc.
    824 12th Avenue
    Bethlehem, PA 18018
    610-691-5400

    August 29, 2014

    Subject:  Temporary Importation of 0.9% Sodium Chloride w/v Intravenous Infusion in Ecoflac® Plus Containers

    Dear Health Care Provider,

    The purpose of this letter is to inform you of an additional foreign product that B. Braun Medical Inc. (B. Braun) will be providing in the United States (U.S.) to address the critical drug shortage of 0.9% Sodium Chloride for Injection. Due to the shortage of 0.9% Sodium Chloride Injection products in the U.S., B. Braun is coordinating with the U.S. Food and Drug Administration (FDA) to temporarily import foreign Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac® plus container into the U.S. market.  The foreign product is manufactured at an FDA inspected B. Braun sterile injectable facility in Melsungen, Germany which is currently in compliance with FDA regulations. 

    At this time, FDA is not objecting to the importation and distribution of Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac® plus container product by B. Braun to address the critical U.S. shortage of 0.9% Sodium Chloride Injection. Importation or distribution of B. Braun’s Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac® plus container by any entity other than B. Braun and its authorized distributor(s), is not within the scope of this decision and may be subject to enforcement action by the FDA. FDA has not approved B. Braun’s Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac® plus container in the United States.

    Effective immediately and during this temporary period, B. Braun will offer the following presentations of B. Braun’s Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac® plus container:

    Product Name  Volume Ingredients
    Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac® plus container 500 mL Each 500 mL contains: Sodium Chloride 4.5 g,
    Water for Injections to 500 mL Electrolytes per 500 mL is Sodium 77 mmol, Chloride 77 mmol

    Ecoflac plus container- Not made with natural rubber latex, PVC, or DEHP.

    Indications and Usage and Dosage Administration

    The foreign unapproved product, packaged in a semi-rigid Ecoflac® (polyethylene plastic) container, contains the same active ingredient in the same concentration as the 0.9% Sodium Chloride Injection products approved in the U. S., packaged in the flexible plastic EXCEL®  (ethylene-propylene copolymer) bag. As such, clinical practice pertaining to indication, usage and dosage administration for Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac® plus container is the same as with the EXCEL® containers.

    However, some key differences between the Ecoflac® and EXCEL® container packaging and labeling are described below in the Product Comparison Table.

    It is also important to note that the Ecoflac® plus container is a semi rigid plastic bottle. However, no venting is necessary during infusion. Ecoflac® plus collapses completely when emptying.

    Ecoflac® plus container and carton labeling may include barcodes that may not register accurately in the U.S. scanning systems. Institutions should manually input the product into their systems and confirm that barcode systems do not provide incorrect information when the product is scanned. Alternative procedures should be followed to assure that the correct drug product is being used and administered to individual patients.

    Reporting Adverse Events

    To report adverse events or quality problems with B. Braun’s Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac® plus container, please contact the B. Braun Clinical and Technical Support Department at 1-800-854-6851. Adverse events that may be related to the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program either via phone, online, regular mail or fax:

    Thank you for your commitment to B. Braun’s IV solution products.

    Rick Williamson
    Vice President of Pharmaceutical Marketing

    PRODUCT COMPARISON TABLE
    ItemGerman Product – Ecoflac® ContainerUS Product - EXCEL® Container 
    Product Drawing

    Ecoflac® Plus

    Ecoflac Container Illustration

    EXCEL®

    EXCEL Container Illustration
    Product Description0.9% w/v Sodium Chloride BP0.9% Sodium Chloride Injection USP
    Product Code9999-10L8001
    Unit Bar CodeNoYes (NDC and Lot/Exp)
    NDC #0264-9999-100264-7800-10
    Volume500 mL500 mL
    Case Quantity10 units per case24 units per case
    Storage ConditionDo not store above 25°CStore at room temperature (25°C)
    Shelf Life36 months30 months
    IngredientsEach 500 mL contains:
    Sodium Chloride EP 450 mg,
    Water for Injection EP to 500 mL
    Total Electrolytes per 500 mL:
    Sodium 77 mEq, Chloride 77 mEq
    Each 500 mL contains:
    Sodium Chloride USP 450 mg,
    Water for Injection USP to 500 mL.
    Total Electrolytes per 500 mL:
    Sodium 77 mEq, Chloride 77 mEq
    Container TypeEcoflac® Plus, Polyethylene Plastic Containers (semi rigid plastic bottle)Excel®, Primary plastic container with a clear overwrap (flexible plastic bag)
    Container material Low Density Polyethylene (LDPE)Copolymer of ethylene and propylene
    Container DescriptionBlow/Fill/Seal (BFS)Form/Fill/Seal (FFS)
    PVC, DEHP, LatexNoNo
    OverwrapNoYes
    Closure DescriptionTwin cap with peel tab coverAdditive port with elastomeric stopper, Administration port with plastic cover
    Pictures of Difference in Container Port System

    Twin Port with peel tab cover and two interchangeable access ports with thermoplastic elastomeric septum

    Ecoflac Port Illustration

    Separate additive and administration ports

    EXCEL Port Illustration
    Additive Port MaterialThermoplastic elastomerSynthetic Isoprene
    Needle Size18-21 gauge18-22 gauge
    Additive Volume120 mL50 mL
    Spike Port ResealableYesNo
    Pressure InfusionNo Yes, not to exceed 300mm Hg
    Sterilization ProcessTerminal Steam Sterilization
    Sterility Test (Ph. Eur.)
    Sterility Assurance Level of 10-6
    Terminal Steam Sterilization
    Parametric Release
    Sterility Assurance Level of 10-6

  • PRINCIPAL DISPLAY PANEL

    Sodium Chloride 0.9% w/v Intravenous Infusion BP

    Expel all air before pressure infusion.

    This 500 ml contains:
    Electrolytes                            mmol
    Sodium                                      77
    Chloride                                    77
    Sodium Chloride                       4.5 g
    Water for injections

    pH                                            4.0 - 7.0

    Solution for infusion. For intravenous use only. Use as directed by a medical practitioner. Do not use if container or closure is damaged. For single use only. Do not reconnect partially used containers.

    Contents: 500 ml

    Discard any unused contents. Solutions containing visible solid particles should not be administered. Keep out of the reach and sight of children. Do not store above 25 °C. In case of an adverse reaction, infusion must be stopped immediately. No other medication or substance should be added to this fluid unless the compatibility is known. Thorough and careful mixing of any additive is mandatory. For further information, see enclosed package leaflet.

    LOT
    EXP:

    Recycle 4 PE-LD 

    B. Braun Melsungen AG
    D-34209 Melsungen, Germany

    5/12619414/0914

    Container Label
  • INGREDIENTS AND APPEARANCE
    SODIUM CHLORIDE 
    sodium chloride injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0264-9999
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE450 mg  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0264-9999-1010 in 1 CASE
    1500 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE08/19/2014
    Labeler - B. Braun Medical Inc. (002397347)