FDA Label for Sodium Chloride

Health Care Provider Letter

Important Prescribing Information

September 3, 2024

Dear Healthcare Professional,

In order to address shortages of critical irrigation drug products, ICU Medical is coordinating with the U.S. Food and Drug Administration (FDA) to increase the availability of products from our portfolio which are manufactured and intended for the Canadian market. Temporarily and effective immediately, ICU Medical will make available for sale in the US the products listed below. These products are manufactured in the same facility and to the same specifications as ICU Medical's FDA-approved drug products; however, they are not labeled with current FDA-approved labeling. The information contained in this letter pertains only to the products listed below, which are not approved by FDA.

There are some key differences in the labeling between the U.S. FDA-approved products and the Canadian products. Please see the product comparison tables at the end of this letter for additional information.

The barcode may not register accurately on the U.S. scanning systems. Institutions should manually input the product into their systems to confirm that barcode systems provide correct 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.

The U.S. FDA-approved products are available by prescription only in the U.S. However, the Canadian products do not have the statement "Rx only" on their labeling.

Please refer to the FDA-approved package insert for the full prescribing information of each drug product.

If you have any questions about ordering SRB irrigation products, please contact ICU Medical Customer Care at (877) 946-7747 or email [email protected]. For medical questions, please call ICU Medical Information at (800) 241-4002 or email [email protected].

To report adverse events or quality problems experienced with the use of this product, please call ICU Medical Global Complaint Management at (844) 654-7780 or email [email protected].

Adverse events or quality problems experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting Program either online, or regular mail, or by fax:

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call (800) 332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to (800) FDA-0178 (1-800-332-0178).

Our team is working with customers to mitigate the impact of this shortage and are committed to returning to full levels of production as soon as possible.

Sincerely,

Signature - sodium 01

Stuart Green
Senior Director, Quality

Representative Product Labels Comparison Tables

Sterile Water for Irrigation, USP

	US FDA Approved Product	Canadian Approved Product
Product Name	Sterile Water for Irrigation, USP	Sterile Water for Irrigation, USP
Indications	For irrigation only	For intraperitoneal, irrigation and topical use only
Active Ingredients	Sterile Water	Sterile Water
Additional Information	pH 5.5 (5.0 – 7.0)	pH approx. 5.5
Storage Conditions	Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]	20 to 25°C
Container Type	AQUALITE™ Semi-Rigid Bottle	AQUALITE™ Semi-Rigid Bottle
Language	English	English and French
Additional Product Identifier	NDC number	DIN and product catalog number
Barcode	GS1 Primary Data Structure Includes product NDC Number	GS1 Primary Data Structure Includes Canada Manufacturer Number and unique product code

0.9% Sodium Chloride Irrigation, USP

	US FDA Approved Product	Canadian Approved Product
Product Name	0.9% Sodium Chloride Irrigation, USP	0.9% Sodium Chloride Irrigation, USP
Indications	Isotonic solution for irrigation	For intraperitoneal, irrigation and topical use only
Active Ingredients	Each 100 mL contains sodium chloride, 900 mg	Each mL contains: Sodium chloride 9 mg
Additional Information	pH 5.6 (4.5 – 7.0)	pH approx. 5.6
Storage Conditions	Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]	20 to 25°C
Container Type	AQUALITE™ Semi-Rigid Bottle	AQUALITE™ Semi-Rigid Bottle
Language	English	English and French
Additional Product Identifier	NDC number	DIN and product catalog number
Barcode	GS1 Primary Data Structure Includes product NDC Number	GS1 Primary Data Structure Includes Canada Manufacturer Number and unique product code

Principal Display Panel - 250 Ml Bottle Label

250 mL

Sterile Solution

DIN 00037834
N° 06138125

AQUALITE™

0.9%

Sodium Chloride
Irrigation USP

For Intraperitoneal, Irrigation and Topical
Use • NOT FOR INJECTION • Nonpyrogenic
• Single-Use

Use only if solution is clear and seal intact.
Discard unused portion. Each mL contains:
Sodium chloride 9 mg. May contain NaOH/HCl for
pH adjustment. Contains no bacteriostat. Dosage:
As directed. Do not heat over 66°C. Storage: 20 to
25°C. Protect from freezing.

pH approx. 5.6

Questions or Concerns

ICU Medical Canada Inc.
Saint-Laurent, QC H4S 0A9

RL-7298

LOT
EXP

Principal Display Panel - 250 mL Bottle Label - sodium 06

Principal Display Panel - 500 Ml Bottle Label

500 mL

Sterile Solution

DIN 00037834
N° 06138023

AQUALITE™

0.9%

Sodium Chloride Irrigation USP

For Intraperitoneal, Irrigation and Topical Use
• NOT FOR INJECTION • Nonpyrogenic • Single-Use

Use only if solution is clear and seal
intact. Discard unused portion. Each
mL contains: Sodium chloride 9 mg.
May contain NaOH and/or HCl for pH
adjustment. Contains no bacteriostat.
Dosage: As directed. Do not heat over
66°C. Storage: 20 to 25°C. Protect from
freezing.

pH approx. 5.6

Questions or Concerns
ICU Medical Canada Inc.
Saint-Laurent, QC H4S 0A9

icumedical

RL-7297

LOT
EXP

Principal Display Panel - 500 mL Bottle Label - sodium 07

Principal Display Panel - 1000 Ml Bottle Label

1000 mL
AQUALITE™

DIN 00037834
N° 07138019

0.9%

Sodium Chloride
Irrigation USP

For Intraperitoneal, Irrigation and Topical Use
•NOT FOR INJECTION

Sterile Solution • Nonpyrogenic • Single-Dose
Use only if solution is clear and seal intact.
Discard unused portion. Each mL contains:
Sodium chloride 9 mg. May contain NaOH/HCl
for pH adjustment. Contains no bacteriostat.
Usual Dose: As directed. Do not heat
container over 66°C. Storage: 20 to 25°C.
Protect from freezing.

pH approx. 5.6

Questions or Concerns
ICU Medical Canada Inc.
Saint-Laurent, QC H4S 0A9

icumedical

RL-7286

LOT
EXP

Principal Display Panel - 1000 mL Bottle Label - sodium 08