{"effective_time":"20251105","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 Signature Representative Product Label Representative Product Label Representative Product Label Representative Product Label"],"health_care_provider_letter_table":["
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
","
Product DescriptionSizeCanadian DINNDC
Sterile Water for Irrigation, USP1000 mLDIN 000382290990-8139-10
0.9% Sodium Chloride Irrigation, USP250 mLDIN 000378340990-5138-25
0.9% Sodium Chloride Irrigation, USP500 mLDIN 000378340990-5138-50
0.9% Sodium Chloride Irrigation, USP1000 mLDIN 000378340990-8138-10
","
US FDA Approved ProductCanadian Approved Product
Product NameSterile Water for Irrigation, USPSterile Water for Irrigation, USP
IndicationsFor irrigation onlyFor intraperitoneal, irrigation and topical use only
Active IngredientsSterile WaterSterile Water
Additional InformationpH 5.5 (5.0 – 7.0)pH approx. 5.5
Storage ConditionsStore at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]20 to 25°C
Container TypeAQUALITE™ Semi-Rigid BottleAQUALITE™ Semi-Rigid Bottle
LanguageEnglishEnglish and French
Additional Product IdentifierNDC numberDIN and product catalog number
BarcodeGS1 Primary Data Structure Includes product NDC NumberGS1 Primary Data Structure Includes Canada Manufacturer Number and unique product code
","
US FDA Approved ProductCanadian Approved Product
Product Name0.9% Sodium Chloride Irrigation, USP0.9% Sodium Chloride Irrigation, USP
IndicationsIsotonic solution for irrigationFor intraperitoneal, irrigation and topical use only
Active IngredientsEach 100 mL contains sodium chloride, 900 mgEach mL contains: Sodium chloride 9 mg
Additional InformationpH 5.6 (4.5 – 7.0)pH approx. 5.6
Storage ConditionsStore at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]20 to 25°C
Container TypeAQUALITE™ Semi-Rigid BottleAQUALITE™ Semi-Rigid Bottle
LanguageEnglishEnglish and French
Additional Product IdentifierNDC numberDIN and product catalog number
BarcodeGS1 Primary Data Structure Includes product NDC NumberGS1 Primary Data Structure Includes Canada Manufacturer Number and unique product code
"],"id":"88626263-25a6-4163-98c3-5bb342c3a8ec","openfda":{},"package_label_principal_display_panel":["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 Principal Display Panel - 1000 mL Bottle Label"],"set_id":"f484b04b-1b7d-4fce-ac24-e0db271baf76","spl_product_data_elements":["Sterile Water Water WATER WATER"],"version":"3"}