{"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, by 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 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 Surveillance 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 ) DCHP Letter 1 DCHP Letter 2 DCHP Letter 3 DCHP Letter 4 DCHP Letter 5 DCHP Letter 6 DCHP Letter 7"],"id":"f7531c41-674a-4d2b-b292-ead2dd7372b7","openfda":{},"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label JB0304 1000 mL DIN 02014882 Sterile WATER for Injection USP EAU stérile pour injection USP Sterile WATER / EAU stérile Not for Direct Infusion Ne pas utilizer pour perfuser directment H 2 O PHARMACY BULK PACKAGE / CONDITIONNEMENT EN VRAC POUR LA PHARMACIE SINGLE PUNCTURE, MULTIPLE DISPENSING / PERFORATION UNIQUE, DISPENSATION MULTIPLE DISCARD UNUSED PORTION / JETER TOUTE PARTIE INUTILISÉE APPROX mOsmol/L 0 APPROX pH 5.5 NO ANTIMICROBIAL AGENT OR OTHER SUBSTANCE HAS BEEN ADDED / AUCUN AGENT ANTIMICROBIEN OU AUTRE SUBSTANCE NA ÉTÉ AJOUTÉ CAUTIONS: SQUEEZE AND INSPECT BAG / SEE DIRECTIONS FOR USE / MUST NOT BE USED IN SERIES CONNECTIONS / STORE AT 15°C ET 25°C MISES EN GARD : PRESSER ET INSPECTOR LA POCHE / CONSULTER LE MODE D’ÉMPLOI / NE PAS UTILISER POUR LES RACCORDS EN SÉRIE / CONSERVER ENTRE 15°C ET 25°C CONTAINS NO MORE THAN 25 µg/L OF ALUMINUM / NE CONTINENT PAS PLUS DE 25 µg/L D’ALUMINIUM NONPYROGENIC / STERILE / APYROGENE / STÉRILE HYPOTONIC / ADMIX ONLY / HYPTONIQUE / POUR MÉLANGE SUELEMENT DOSAGE: PRESCRIBING INFORMATION AVAILABLE ON REQUEST / POSOLOGIE : RENSEIGNEMENTS POSOLOGIQUES DISPONIBLES SUR DEMANDE H 2 O Label VIAFLEX PVC CONTAINER / CONTENANT EN PVC VIAFLEX BAXTER AND VIAFLEX TRADEMARKS OF BAXTER INTERNATIONAL, INC. BAXTER ET VIAFLEX SONT DES MARQUES DE COMMERCE DE BAXTER INTERNATIONAL, INC. Baxter Logo Baxter Corporation Mississauga ON L5N 0C2 No Latex Label 07-25-77-318 JB-03-04 12 – 1000 mL units Store at 15°C to 25°C Sterile Water for Injection USP Lot: WWWWWWWWW EXP: 2099 99 2DBarcode (01)20809080000528 Pharmacy Bulk Container Label 0338-9782-01 1 of 2 Container Label 0338-9782-01 2 of 2"],"set_id":"b28369a7-ea39-474a-b7da-b6c5f4642588","spl_product_data_elements":["Sterile Water Water WATER WATER"],"version":"4"}