STERILE WATER- water irrigant

Sterile Water by

Drug Labeling and Warnings

Sterile Water by is a Prescription medication manufactured, distributed, or labeled by ICU Medical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTH CARE PROVIDER LETTER

Important Prescribing Information

September 3, 2024

Subject: Temporary distribution of Sterile water and 0.9% Sodium chloride Semi-Rigid Bottle (SRB) Irrigation with non-U.S. labeling to address drug shortages

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.

Product Description	Size	Canadian DIN	NDC
Sterile Water for Irrigation, USP	1000 mL	DIN 00038229	0990-8139-10
0.9% Sodium Chloride Irrigation, USP	250 mL	DIN 00037834	0990-5138-25
0.9% Sodium Chloride Irrigation, USP	500 mL	DIN 00037834	0990-5138-50
0.9% Sodium Chloride Irrigation, USP	1000 mL	DIN 00037834	0990-8138-10

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 uscustomercare@icumed.com. For medical questions, please call ICU Medical Information at (800) 241-4002 or email Med-info_US@icumed.com.

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 ProductComplaintsPP@icumed.com.

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,

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 - 1000 mL Bottle Label

1000 mL

Sterile
Solution

DIN 00038229
N° 07139019

AQUALITE™
Sterile Water for Irrigation, USP

100%
FOR INTRAPERITONEAL,
IRRIGATION AND TOPICAL USE
ONLY NOT FOR INJECTION
Nonpyrogenic Single-Use
Contains no antimicrobial or other
added substance. Dosage: As
directed. Do not heat container over
66°C. Discard unused portion. Storage:
20 to 25°C. Protect from freezing.

pH approx. 5.5

Questions or Concerns

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

RL-7288

LOT
EXP

INGREDIENTS AND APPEARANCE

STERILE WATER 
water irrigant

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0990-8139
Route of Administration	IRRIGATION

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	1 mL  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0990-8139-10	12 in 1 CASE	08/01/2024
1		1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE		08/01/2024

Labeler - ICU Medical Inc. (118380146)