{"effective_time":"20241218","health_care_provider_letter":["Health Care Professional Letter Reporting Adverse Events or Product Quality Issues To report adverse events associated with these imported products, please call Baxter at 1-866-888-2472, or fax: 1-800-759-1801. Adverse events or quality problems experienced with the use of these imported products may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, or by regular mail or by fax: • Complete and submit the report Online : https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program • Regular mail or Fax : Download form https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (1-800-332-0178). To report product quality issues associated with these imported products, please contact Baxter Product Surveilance through Baxter Product Feedback Portal https://productfeedback.baxter.com/ Please refer to the FDA-approved prescribing information for each drug product listed below: • Sterile Water for Injection USP (click https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018632s051lbl.pdf ) • 70% Dextrose Injection USP (click https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020047s021lbl.pdf ) DHCP Letter 1 of 7 DHCP Letter 2 of 7 DHCP Letter 3 of 7 DHCP Letter 4 of 7 DHCP Letter 5 of 7 DHCP Letter 6 of 7 DHCP Letter 7 of 7"],"id":"a9080a1a-0ee3-4ed8-ba01-3b39c42f9d12","openfda":{},"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label JB0297 3000 mL DIN 02014874 70% Dextrose Injection USP Dextrose à 70% USP, Injectable DEXTROSE 70% 2D Barcode (01)00809080000654 Pharmacy Use Only / Dilute Before Infusing Pour Usage Par La Pharma- cie Seulement / Diluer Avant La Perfusion Not for Direct Infusion / Ne pa utilier pour perfuser directement HYPERTONIC / HYPERTONIQUE CONTAINS NO MORE THAN 25 µg/l OF ALUMINUM / NE CONTENT PAS PLUS DE 25 µg/l D’ALUMINIUM APPROX mOsmol/L – 3530 APPROX pH 4.0 INTRAVENOUS FLUID AND NUTRIENT REPLENISHMENT / RECHARGE LIQUIDIENNE ET NUTRIMENT PAR INJECTION INTRAVEINEUSE PER 100 mL DEXTROSE HYDROUS USP – 70 g / WATER FOR INJECTION USP qs PAR 100 mL DEXTROSE HYDRATE USP – 70 g / EAU POUR INJETION USP qs COLOUR VARIATION FROM LIGHT YELLOW TO AMBER IS NORMAL AND DOES NOT ALTER EFFICACY / IL EST NOR- MAL QUE LA COULEUR VARIE D’UN JAUNE PALE A UN JAUNE AMBRE ET CELA N’AFFECTE PAS L’EFFICACITE AFFIX ACCOMPANYING LABEL FOR DATE AND TIME OF ENTRY / APPOSER UNE ETIQUETTE ET INSCRIRE LA DATE ET L’HEURE DU PRELEVEMENT INITIAL / DISCARD UNUSED CONTENTS WITHIN 4 HOURS OF INITIAL ENTRY / JETER LE CONTENANT 4 HEURES APRES LE PREMIER PRELEVEMENT CAUTIONS SQUEEZE AND INSPECT BAG / SEE DIREC- TIONS FOR USE / STORE AT 15°C TO 25°C ATTENTIONS PRESSER ET INSPECTER LE SAC / VOIR MODE D’EMPLOI / GARDER ENTIRE 15°C ET 25°C NONPYROGENIC / STERILE / APYROGENE / STERILE PRESCRIBING INFORMATION AVAILABLE ON REQUEST / INFORMA- TION POSOLOGIQUE DISPONIBLE SUR DEMANDE VIAFLEX PVC CONTAINER/CONTENANT DE PVC BAXTER AND VIAFLEX ARE TRADEMARKS OF BAXTER INTERNATIONAL INC BAXTER ET VIAFLEX SONT DE MARQUES DE COMMERCE DE BAXTER INTERNATIONAL INC Baxter Logo BAXTER CORPORATION Mississauga ON L5N 0C2 70% No Latex Label 88-70-20-462 2100 1800 1500 1200 900 600 300 JB-02-97 4 – 3000 mL units Store at 15°C to 25°C 70% Dextrose Injection USP Lot:WWWWWWWWW EXP: 2099 99 2D Barcode (01)20809080000658 Pharmacy Bulk Container Label 0338-9789-01 1 of 2 Container Label 0338-9789-01 2 of 2"],"set_id":"ccade884-95e8-4b29-b199-e6827b709c31","spl_product_data_elements":["Dextrose Dextrose monohydrate DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE WATER"],"version":"5"}