Label: SODIUM CHLORIDE injection

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:

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

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