SODIUM CHLORIDE irrigant
Sodium Chloride by
Drug Labeling and Warnings
Sodium Chloride by is a Prescription medication manufactured, distributed, or labeled by ICU Medical Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
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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, QualityRepresentative 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 NumberGS1 Primary Data Structure
Includes Canada Manufacturer Number and unique product code0.9% 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 NumberGS1 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° 06138125AQUALITE™
0.9%
Sodium Chloride
Irrigation USPFor Intraperitoneal, Irrigation and Topical
Use NOT FOR INJECTION Nonpyrogenic
Single-UseUse 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 0A9RL-7298
LOT
EXP
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PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
500 mL
Sterile Solution
DIN 00037834
N° 06138023AQUALITE™
0.9%
Sodium Chloride Irrigation USP
For Intraperitoneal, Irrigation and Topical Use
NOT FOR INJECTION Nonpyrogenic Single-UseUse 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 0A9icumedical
RL-7297
LOT
EXP
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PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Label
1000 mL
AQUALITE™DIN 00037834
N° 071380190.9%
Sodium Chloride
Irrigation USPFor Intraperitoneal, Irrigation and Topical Use
NOT FOR INJECTIONSterile 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 0A9icumedical
RL-7286
LOT
EXP
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INGREDIENTS AND APPEARANCE
SODIUM CHLORIDE
sodium chloride irrigantProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 0990-5138 Route of Administration IRRIGATION Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 900 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0990-5138-25 24 in 1 CASE 08/01/2024 1 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC: 0990-5138-50 24 in 1 CASE 08/01/2024 2 500 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 SODIUM CHLORIDE
sodium chloride irrigantProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 0990-8138 Route of Administration IRRIGATION Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 900 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0990-8138-10 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)
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