{"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":"db478972-6e08-47d1-841c-92b4051a0527","openfda":{"brand_name":["Sodium Chloride"],"generic_name":["SODIUM CHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Baxter Healthcare Corporation"],"package_ndc":["0338-9791-01","0338-9791-40","0338-9793-01","0338-9793-12","0338-9808-01","0338-9808-24"],"product_ndc":["0338-9791","0338-9793","0338-9808"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"rxcui":["1807633","1807634","1807639"],"spl_id":["db478972-6e08-47d1-841c-92b4051a0527"],"spl_set_id":["93aeac13-41de-4452-9f38-d6b4f38ada30"],"substance_name":["SODIUM CHLORIDE"],"unii":["451W47IQ8X"]},"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Baxter Logo Trademark A6C1322US SODIUM CHLORIDE INJECTION 50 100 150 200 250ml 0.9% Sodium Chloride [Strength] 250ml: 2.25g [Description] This product is a clear, colorless 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: H19994066 AA [Drug Marketing Authorization Holder] [Manufacturer] Name: Baxter Healthcare (Shanghai) Co., Ltd. Address: No. 388, Tingzhu Road, Jinshan District, Shanghai Barcode (01)00303389791010 LOT MFG EXP 0.9% Sodium Chloride Injection 250ml X 40 LOT S0000000 EXP YYYY-MM A6C1322US 1C/N LIC H19994066 0.9% Sodium Chloride Injection 250ml X 40 LOT S0000000 EXP YYYY-MM MFG YYYY-MM-DD 1C/N 0000 Baxter Logo Trademark A6C1323US SODIUM CHLORIDE INJECTION 100 200 300 400 500ml 0.9% Sodium Chloride [Strength] 500ml: 4.5g [Description] This product is a clear, colorless 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: H19983148 AA [Drug Marketing Authorization Holder] [Manufacturer] Name: Baxter Healthcare (Shanghai) Co., Ltd. Address: No. 388, Tingzhu Road, Jinshan District, Shanghai Barcode (01)00303389808015 LOT MFG EXP 0.9% Sodium Chloride Injection 500ml X 24 LOT S0000000 EXP YYYY-MM A6C1323US 1C/N LIC H19983148 0.9% Sodium Chloride Injection 500ml X 24 LOT S0000000 EXP YYYY-MM MFG YYYY-MM-DD 1C/N 0000 Baxter Logo Trademark A6C1324US SODIUM CHLORIDE INJECTION 100 200 300 400 500 600 700 800 900 1000ml 0.9% Sodium Chloride [Strength] 1000ml: 9g [Description] This product is a clear, colorless 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: H19983149 AA [Drug Marketing Authorization Holder] [Manufacturer] Name: Baxter Healthcare (Shanghai) Co., Ltd. Address: No. 388, Tingzhu Road, Jinshan District, Shanghai Barcode (01)00303389793014 LOT MFG EXP 0.9% Sodium Chloride Injection 1000ml X 12 LOT S0000000 EXP YYYY-MM A6C1324US 1C/N LIC H19983149 0.9% Sodium Chloride Injection 1000ml X 12 LOT S0000000 EXP YYYY-MM MFG YYYY-MM-DD 1C/N 0000 Sodium Chloride A6C1322US Representative Carton Label 1.jpg Sodium Chloride A6C1322US Representative Carton Label 2.jpg Sodium Chloride A6C1323US Representative Carton Label 1.jpg Sodium Chloride A6C1323US Representative Carton Label 2.jpg Sodium Chloride A6C1324US Representative Carton Label 1.jpg Sodium Chloride A6C1324US Representative Carton Label 2.jpg"],"set_id":"93aeac13-41de-4452-9f38-d6b4f38ada30","spl_product_data_elements":["Sodium Chloride Sodium Chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER Sodium Chloride Sodium Chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER Sodium Chloride Sodium Chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER"],"spl_unclassified_section":["PACKAGE INSERT Spec301US Image 1.jpg Spec301US Image 2.jpg Spec301US Image 3.jpg Spec301US Image 4.jpg Spec303US Image 1.jpg Spec303US Image 2.jpg Spec303US Image 3.jpg Spec303US Image 4.jpg"],"version":"4"}