{"effective_time":"20230201","health_care_provider_letter":["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: Phone: 1-800-FDA-1088 Online: www.fda.gov/Safety/MedWatch Regular Mail: use postage-paid FDA form 3500 available at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms and mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787 Fax: 1-800-FDA-0178 Thank you for your commitment to B. Braun’s IV solution products. Rick Williamson Vice President of Pharmaceutical Marketing PRODUCT COMPARISON TABLE Item German Product – Ecoflac® Container US Product - EXCEL® Container Product Drawing Ecoflac® Plus EXCEL® Product Description 0.9% w/v Sodium Chloride BP 0.9% Sodium Chloride Injection USP Product Code 9999-10 L8001 Unit Bar Code No Yes (NDC and Lot/Exp) NDC # 0264-9999-10 0264-7800-10 Volume 500 mL 500 mL Case Quantity 10 units per case 24 units per case Storage Condition Do not store above 25°C Store at room temperature (25°C) Shelf Life 36 months 30 months Ingredients Each 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 Type Ecoflac® 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 Description Blow/Fill/Seal (BFS) Form/Fill/Seal (FFS) PVC, DEHP, Latex No No Overwrap No Yes Closure Description Twin cap with peel tab cover Additive 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 Separate additive and administration ports Additive Port Material Thermoplastic elastomer Synthetic Isoprene Needle Size 18-21 gauge 18-22 gauge Additive Volume 120 mL 50 mL Spike Port Resealable Yes No Pressure Infusion No Yes, not to exceed 300mm Hg Sterilization Process Terminal Steam Sterilization Sterility Test (Ph. Eur.) Sterility Assurance Level of 10 -6 Terminal Steam Sterilization Parametric Release Sterility Assurance Level of 10 -6 Ecoflac Container Illustration EXCEL Container Illustration Ecoflac Port Illustration EXCEL Port Illustration"],"health_care_provider_letter_table":["
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
","
PRODUCT COMPARISON TABLE
ItemGerman Product – Ecoflac® ContainerUS Product - EXCEL® Container
Product DrawingEcoflac® PlusEXCEL®
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 mEqEach 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 SystemTwin Port with peel tab cover and two interchangeable access ports with thermoplastic elastomeric septumSeparate additive and administration ports
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 10-6Terminal Steam Sterilization Parametric Release Sterility Assurance Level of 10-6
"],"id":"10cbece4-0500-4fe9-a2ad-83889213686c","openfda":{},"package_label_principal_display_panel":["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: B. Braun Melsungen AG D-34209 Melsungen, Germany 5/12619414/0914 Recycle 4 PE-LD Container Label"],"set_id":"271e8b0f-d051-48a7-9093-8b53078a6a07","spl_product_data_elements":["Sodium Chloride Sodium Chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER"],"version":"2"}