{"effective_time":"20250124","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. 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 also refer to the local prescribing information of the imported product, translated into English, available for: • 0.9% Sodium Chloride Injection (click https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/723233 ) • 5% Glucose Injection (click https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/723235 ) • 10% Glucose Injection (click https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/723237 ) • 5% Glucose/0.9% Sodium Chloride Injection (click https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/723238 ) Please refer to the FDA-approved prescribing information for each drug product listed below: • 0.9% Sodium Chloride Injection USP (click https://www.dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=f55bd888-5e01-474d-871b-24654c070178&type=pdf&name=f55bd888-5e01-474d-871b-24654c070178 ) • 5% Dextrose Injection USP (click https://www.dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=3bb406a9-f5cb-403a-b1bb-5c4facbea3d5&type=pdf&name=3bb406a9-f5cb-403a-b1bb-5c4facbea3d5 ) • 10% Dextrose Injection USP (click https://www.dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=3bb406a9-f5cb-403a-b1bb-5c4facbea3d5&type=pdf&name=3bb406a9-f5cb-403a-b1bb-5c4facbea3d5 ) • 5% Dextrose/0.9% Sodium Chloride Injection USP (click https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016678s007,016683s103,016687s104,016689s107,016697s098lbl.pdf ) DHCP Letter 1.jpg DHCP Letter 2.jpg DHCP Letter 3.jpg DHCP Letter 4.jpg DHCP Letter 5.jpg DHCP Letter 6.jpg DHCP Letter 7.jpg DHCP Letter 8.jpg DHCP Letter 9.jpg DHCP Letter 10.jpg DHCP Letter 11.jpg"],"id":"44619e67-57be-4e25-bd6e-1d0bd47d0f51","openfda":{},"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Baxter Logo Trademark A6C0162US GLUCOSE INJECTION 50 100 150 200 250ml 10% GLUCOSE [Strength] 250ml: 25g [Description] This product is a colorless or almost colorless clear liquid [Dosage and Administration] Intravenous drip See the package insert for details For details of [Indications], [Adverse Reactions], [Contraindications], and [Precautions], please refer to the package insert [Storage] Store in overwrap The solution should be clear and should be used up at one time Inspect the inner bag by squeezing it and discard solution if leakage occurs License Number: H19994063 AA [Drug Marketing Authorization Holder] [Manufacturer] Name: Baxter Healthcare (Shanghai) Co., Ltd. Address: No. 388, Tingzhu Road, Jinshan District, Shanghai BarCode (01) 00303389797012 LOT MFG EXP 10% Glucose Injection 250ml X 40 LOT S0000000 EXP YYYY-MM A6C0162US 1C/N LIC H19994063 10% Glucose Injection 250ml X 40 LOT S0000000 EXP YYYY-MM MFG YYYY-MM-DD 1C/N 0000 A6C0162US Representative Carton Label 1.jpg A6C0162US Carton Label 2.jpg"],"set_id":"11a50ce4-7be1-4891-9683-cc24beb75139","spl_product_data_elements":["Glucose Dextrose Anhydrous DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE WATER"],"spl_unclassified_section":["PACKAGE INSERT SPC302US Image 1.jpg SPC302US Image 2.jpg SPC302US Image 3.jpg SPC302US Image 4.jpg"],"version":"4"}